EXPLANATORY STATEMENT

APPLICATION A424

fortification of foods with calcium

FOOD STANDARDS AUSTRALIA NEW ZEALAND (FSANZ)

FSANZ’s role is to protect the health and safety of people in Australia and New Zealand through the maintenance of a safe food supply.  FSANZ is a partnership between ten governments: the Commonwealth; Australian States and Territories; and New Zealand.  It is a statutory authority under Commonwealth law and is an independent, expert body.

FSANZ is responsible for developing, varying and reviewing standards and for developing codes of conduct with industry for food available in Australia and New Zealand covering labelling, composition and contaminants.  In Australia, FSANZ also develops food standards for food safety, maximum residue limits, primary production and processing and a range of other functions including the coordination of national food surveillance and recall systems, conducting research and assessing policies about imported food.

The FSANZ Board approves new standards or variations to food standards in accordance with policy guidelines set by the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) made up of Commonwealth, State and Territory and New Zealand Health Ministers as lead Ministers, with representation from other portfolios.  Approved standards are then notified to the Ministerial Council.  The Ministerial Council may then request that FSANZ review a proposed or existing standard.  If the Ministerial Council does not request that FSANZ review the draft standard, or amends a draft standard, the standard is adopted by reference under the food laws of the Commonwealth, States, Territories and New Zealand.  The Ministerial Council can, independently of a notification from FSANZ, request that FSANZ review a standard.

The process for amending the Australia New Zealand Food Standards Code is prescribed in the Food Standards Australia New Zealand Act 1991 (FSANZ Act).  The diagram below represents the different stages in the process including when periods of public consultation occur.  This process varies for matters that are urgent or minor in significance or complexity.

Final Assessment Stage

The Authority has now completed two stages of the assessment process and held two rounds of public consultation as part of its assessment of this Application.  This Final Assessment Report and its recommendations have been approved by the FSANZ Board and are now being reviewed by the Australia and New Zealand Food Regulation Ministerial Council (ANZFRMC).

If accepted by ANZFRMC, a change to the Australia New Zealand Food Standards Code is published in the Commonwealth Gazette and the New Zealand Gazette and adopted by reference and without amendment under Australian State and Territory food law.

In New Zealand the New Zealand Minister of Health gazettes the food standard under the New Zealand Food Act.  Following gazettal, the standard takes effect 28 days later.

Further Information

Further information on this Application and the assessment process should be addressed to the Standards Liaison Officer at Food Standards Australia New Zealand at one of the following addresses:

Food Standards Australia New Zealand Food Standards Australia New Zealand
PO Box 7186     PO Box 10559
Canberra BC ACT 2610   The Terrace WELLINGTON 6036
AUSTRALIA     NEW ZEALAND
Tel (02) 6271 2222      Tel (04) 473 9942 
email:  slo@foodstandards.gov.au  email:  info@foodstandards.govt.nz

Assessment reports are available for viewing and downloading from the FSANZ website  www.foodstandards.gov.au .  Alternatively paper copies of reports can be requested from the Authority’s Information Officer at either of the above addresses or by emailing info@foodstandards.gov.au including other general inquiries and requests for information.

CONTENTS

CONTENTS

Executive Summary and Statement of Reasons

Regulatory Problem

Objective

Background

Issues

Options

Impacts

Consultation

Conclusion and Statement of Reasons

1. Introduction

1.1 Subject of the Application

2. Regulatory Problem

2.1 Current regulations

2.1.1 Standard 1.3.2 – Vitamins and Minerals

2.2 Current market presence of fruit- and vegetable-based beverages with increased calcium content

2.3 Requested amendment to Standard 1.3.2

2.4 Public health risks

3. Objectives

4. Background

4.1 Development of Standard 1.3.2 – Vitamins and Minerals

4.2 Regulatory Principles for vitamin and mineral addition to general purpose foods

5. Relevant Issues

5.1 Assessment of A424 against the Regulatory Principles for voluntary fortification and issues raised by submitters

5.1.1 Eligibility of calcium for potential fortification

5.1.2 Eligibility of foods for potential fortification

5.2 Assessment of the public health risk of permitting calcium fortification of the requested products, incorporating issues raised by submitters

5.2.1 Risk of excess calcium intake

5.2.2  Risk of increased consumption of substitute foods

5.2.3 Risk of nutrient deficits or imbalances resulting from milk substitution

5.2.4  Potential for increase in sugar consumption

5.2.5 Inappropriateness of juice for infants

5.2.6  Risk of calcium in proposed foods not being bioavailable

5.3 Risk Management

5.3.1 Options for risk management

5.3.2  Labelling statements

5.3.3 Education

5.4  Potential benefits of fortification

5.4.1  Increased calcium intake in some populations

5.4.2 Alternative sources of dietary calcium

6. Regulatory Options

6.1 Option 1 – No approval

6.2 Option 2 – Approval

7. Impacts

7.1 Affected parties

7.2 Impact analysis

7.2.1 Option 1: No approval

7.2.2 Option 2: Approval

8. Consultation

8.1 Notification to the World Trade Organization

9.  Implementation

10. Conclusion and Recommendation

ATTACHMENT 1 - DRAFT VARIATION TO THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE

ATTACHMENT 2 - DIETARY INTAKE ASSESSMENT

ATTACHMENT 3 - SUMMARY OF SUBMISSIONS

ATTACHMENT 4 - REGULATORY PRINCIPLES FOR ADDITION OF VITAMINS AND MINERALS TO FOODS

ATTACHMENT 5 - FIRST REVIEW REPORT

1. Objectives of Review

2.  Review on Grounds Requested by the Ministerial Council

3.  Background

4. Options

5. Ministerial Council Review Grounds

5.1 Inconsistency with the objectives of the legislation which establishes FSANZ

5.2 Protection of public health and safety

5.2.1 Risk of calcium inadequacy/deficiency

5.2.2 Potential to address deficit

5.2.3 Risk of excess calcium intake

5.2.4  Risk of dietary displacement

5.2.5 Overall conclusion in relation to public health and safety

5.3 Inconsistency between domestic and international food standards

5.3.1 Conclusion

5.4 Provision of adequate information to enable informed choice

5.4.1 Conclusion

5.5 Cost burden on industry or consumers

5.5.1 Conclusion

5.6 Other issues relevant to the Policy Guideline

5.6.1 Consistency with National Nutrition Policies and Guidelines

5.6.2 Alcoholic beverages

6. Impact Analysis

7. Conclusion and recommendation

7.1 Statement of Reasons

Attachments

ATTACHMENT 6 - SECOND REVIEW REPORT

1. Introduction

2. Objectives of review

3. Grounds for the Review

4. Background

5. Ministerial Council Review Grounds

5.1 Protection of public health and safety

5.1.1 Role of food regulation in promoting health gain

5.1.2 Risk of calcium inadequacy/deficiency

5.1.3 Potential to address the calcium deficit

5.1.4 Risk of excess calcium intake

5.1.5 Risk of displacement of other nutrients

5.1.6 Risk of increasing rates of overweight and obesity

5.1.7 Risk of increasing dental caries/erosion

5.1.8 Bioavailability of calcium-fortified foods

5.1.9 Impact of milk protein constituents on bone density

5.1.10 Conclusion

5.2 Inconsistency with existing policy guidelines set by the Ministerial Council

5.2.1 Risk of promoting consumption patterns inconsistent with nutrition policies and guidelines of Australia and New Zealand.

5.2.2 Risk of promoting increased consumption of foods high in sugar, salt and fat

5.2.3 Conclusion

5.3 Provision of adequate information to enable informed choice

5.3.1. Perception of fortified foods being ‘healthier’

5.3.2 Labelling requirements

5.3.3 Claims misleading consumers

5.3.4 Effectiveness of calcium-fortified products

5.3.5 Conclusion

6. Review Options

7. Conclusion and recommendation

Attachments

Executive Summary and Statement of Reasons

Food Standards Australia New Zealand (FSANZ) received an Application from Food Liaison Pty Ltd on behalf of Arnott’s Biscuits Limited and Nutrinova Pty Ltd to amend Standard 1.3.2 – Vitamins and Minerals, of the Australia New Zealand Food Standards Code (the Code), to permit the addition of calcium to fruit- and vegetable juices, fruit- and vegetable drinks, fruit cordial, soups and savoury biscuits.  Following Draft Assessment the Applicant notified FSANZ that fruit cordials has been withdrawn from the requested list of foods. Consequently the scope of this Application has narrowed to fruit- and vegetable- juices and drinks, soups and savoury biscuits. Further reference to the Applicant’s requested list of foods in this Report now omits fruit cordials.

Regulatory Problem

Vitamins or minerals are not permitted to be added to general-purpose foods unless the addition of the vitamin or mineral is specifically permitted in Standard 1.3.2 – Vitamins and Minerals and the vitamin or mineral is in a permitted form as specified in the Schedule to Standard 1.1.1 of the Code. 

Objective

Protect the health and safety of the community in their consumption of calcium-fortified fruit juices, fruit drinks, soups and savoury biscuits.

Background

This Application has been assessed against Regulatory Principles for the voluntary vitamin and mineral addition to general purpose foods that were previously clarified and elaborated by FSANZ in 2002 from a previous version developed during the 1990s based on the Codex General Principles for the Addition of Essential Nutrients to Foods (Codex General Principles). 

Issues

Issues considered in this Final Assessment include (with consideration of the dietary intake assessment):

• the eligibility of the nutrient for voluntary fortification;
• the eligibility of the foods proposed for fortification;
• an assessment of the risk of excess calcium intake;
• a consideration of potential effectiveness;
• an assessment of the risk of nutrient deficits or imbalances; and
• consideration of risk management strategies in relation to addressing the inappropriate consumption of calcium-fortified food products.

Options

There are two options for addressing this Application:

                Option 1 – No approval.  Maintain the status quo by not amending the Code to approve the voluntary addition of calcium to the food products requested by the Applicant.

                Option 2 – Approval.  Amend the Code by approving the voluntary addition of calcium to the requested range of food products.

Impacts

The conclusion of the impact analysis is that Option 2, approval of the Application, is the preferred option taking into account the dietary intake assessment and matters raised by submitters.  Some of the specific considerations in reaching this conclusion were as follows:

                There are benefits to consumers of additional and/or alternative food sources of calcium. 

                Dietary intake assessment indicates that there is very little risk of excess consumption of calcium.

                The potential exists to improve the calcium intake of population subgroups whose current intakes are assessed as inadequate.  This potential benefit is estimated to outweigh any risks associated with inappropriate use of the calcium-fortified products as substitutes for dairy foods.

Consultation

A total of 25 submissions were received in response to the Draft Assessment released in December 2002. At Draft Assessment the Application included fruit based cordials in the list of foods to be amended in Standard 1.3.2. Of the submissions, 11 submitters unconditionally supported approval and 10 submitters opposed the Application in its entirety.  Four other submitters either: supported limited permissions (variation of Option 2) or declined to support either option; in each case, the major issue of contention was the proposed permission to fortify cordial with calcium, although in general calcium fortification of fruit- based beverages was more contentious than for vegetable-based beverages, soups or savoury biscuits.

Conclusion and Statement of Reasons

FSANZ approves the draft variation to Standard 1.3.2 to permit the voluntary addition of calcium to fruit- and/or vegetable juices, fruit- and/or vegetable-drinks, soups and savoury biscuits to 25% RDI/ reference quantity – equivalent to a ‘good source of calcium’ content claim, for the following reasons:

                Calcium is considered to be potentially eligible for voluntary fortification (subject to risk assessment) because, in accordance with FSANZ’s Regulatory Principles for the Addition of Vitamins and Minerals to Foods (Regulatory Principles), 30% of more than one population subgroup in both Australia and New Zealand has a customary intake below the (UK) Estimated Average Requirement (EAR) for calcium based on National Nutrition Surveys.

                All foods requested by the Applicant are considered to be eligible for voluntary fortification (subject to risk assessment) since the food categories meet the nutritional criteria set out in FSANZ’s Regulatory Principles.

                Dietary modelling has shown that there are subgroups of the Australian and New Zealand populations who are at risk of inadequate calcium intakes. Low calcium intake is proven to be one of a number of factors contributing to osteoporosis. Increasing intakes of calcium can (over time) significantly reduce the burden of osteoporosis to the community.

                The dietary intake assessment estimates that there would be negligible risk of excess calcium intake based on the addition of calcium to all the requested foods at the maximum levels proposed. There is minimal risk of long-term substitution of milk for calcium-fortified beverages or of an inappropriate increase in fruit- or vegetable beverage consumption as a result of calcium fortification.

                The addition of calcium to all the requested foods has the potential to increase the calcium intake of the population or subgroups of the population whose current intakes are inadequate.  However, this potential benefit depends on the extent to which the permission to voluntarily add calcium is taken up by industry.

                Permission for the voluntary fortification of the requested foods with calcium would provide consumers with additional and/or alternative food sources of calcium.

It is recommended that all requested food categories i.e. fruit- and vegetable juices, fruit- and vegetable- drinks, soups and savoury biscuits be permitted to be voluntarily fortified with calcium to a maximum level of 25% Recommended Dietary Intake (RDI) per reference quantity, which qualifies the food to bear a ‘good source of calcium’ content claim.

1. Introduction

1.1 Subject of the Application

FSANZ received an Application from Food Liaison Pty Ltd on behalf of Arnott’s Biscuits Limited and Nutrinova Pty Ltd to amend Standard 1.3.2 – Vitamins and Minerals, of the Code, to permit the addition of calcium to fruit- and vegetable juices, fruit- and vegetable drinks, fruit cordial, soups and savoury biscuits. 

Following Draft Assessment the Applicant notified FSANZ that the request to permit fortification of fruit cordials had been withdrawn. Consequently the scope of this Application has narrowed to fruit- and vegetable- juices and drinks, soups and savoury biscuits. Further reference to the Applicant’s requested list of foods in this Report now omits fruit cordials.

2. Regulatory Problem

2.1 Current regulations

2.1.1 Standard 1.3.2 – Vitamins and Minerals

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 1.3.2 – Vitamins and Minerals or elsewhere in the Code and the vitamin or mineral is in a permitted form[1].  Standard 1.3.2 regulates the addition of vitamins and minerals to general purpose foods (not special purpose foods e.g. infant formula), and the claims that can be made about the vitamin and mineral content of the foods.  Standard 1.3.2 currently permits the voluntary addition of calcium to certain general purpose foods such as breakfast cereals and most dairy products, however, there is no current permission for the voluntary addition of calcium to the non-dairy products requested by the Applicant.

2.2 Current market presence of fruit- and vegetable-based beverages with increased calcium content

Currently, some fruit- and vegetable-based beverages on the Australian and New Zealand market have an increased calcium content through either regulation in New Zealand as dietary supplements, or in Australia through the lawful use of dairy-based whey ingredients in fruit drinks.

2.3 Requested amendment to Standard 1.3.2

The Applicant requests an amendment to the Table to clause 3 of Standard 1.3.2 to permit the voluntary addition of currently permitted calcium salts specified in the Schedule to Standard 1.1.1 to a range of products so as to allow a maximum claim per reference quantity of 25% Recommended Dietary Intake (RDI)/reference quantity.  The requested foods fall into two categories: those that are already permitted vitamin or mineral fortification i.e. fruit juice, vegetable juice, tomato juice, fruit drinks containing at least 25% fruit juice, and savoury biscuits containing not more than 20% fat, and not more than 5% sugar; and two new categories – soup and vegetable drinks containing at least 25% vegetable juice.  For the new foods, the reference quantities proposed are 200 mL each. 

2.4 Public health risks

Dietary modelling has shown that there are subgroups of the Australian and New Zealand populations that are at risk of inadequate calcium intakes. Low calcium intake, particularly before adult maturity, increases the risk of weaker bones and in later life, of developing osteoporosis. Increasing calcium intakes in these at risk groups may deliver public health benefits in producing healthier bones and teeth, and possibly reducing the burden of osteoporosis to the community.

3. Objectives

In developing or varying a food standard, FSANZ is required by its legislation to meet the three primary objectives set out in section 10 of the FSANZ Act.  These are:

                the protection of public health and safety;

                the provision of adequate information relating to food to enable consumers to make informed choices; and

                the prevention of misleading or deceptive conduct.

In developing and varying standards, FSANZ must also have regard to:

                the need for standards to be based on risk analysis using the best available scientific evidence;

                the promotion of consistency between domestic and international food standards;

                the desirability of an efficient and internationally competitive food industry;

                the promotion of fair trading in food; and

                any written policy guidelines formulated by the Council for the purposes of this paragraph and notified to the Authority.

The specific objectives of this Application are to:

1.              Protect the health and safety of the community in their consumption of calcium-fortified fruit juices, fruit drinks, soups and savoury biscuits.

1.              Ensure that adequate information is provided to enable consumers to make informed choices, should this Application be accepted.

4. Background

4.1 Development of Standard 1.3.2 – Vitamins and Minerals

Standard A9 – Vitamins and Minerals, of the former Australian Food Standards Code was gazetted in 1987.  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 1984 (NZFR).  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 NZFR was the subject of Proposal P166 – Vitamins and minerals in general purpose foods, from which the joint Standard 1.3.2 – Vitamins and Minerals of the Code was developed. 

4.2 Regulatory Principles for vitamin and mineral addition to general purpose foods

Regulatory Principles for the voluntary vitamin and mineral addition to general purpose foods were first developed by FSANZ’s predecessor, the National Food Authority, in 1995.  They were derived from the Codex General Principles for the Addition of Essential Nutrients to Foods (Codex General Principles) developed by the Codex Alimentarius Commission.  As noted above, these Regulatory Principles were revised in 1999 through Proposal P166 as part of the development of joint Australia New Zealand food standards.

FSANZ’s Regulatory Principles for the addition of vitamins and minerals to foods were clarified and elaborated in order to provide a basis for future decision-making in relation to relevant applications and proposals until such time as the Australia and New Zealand Food Regulation Ministerial Council (the Ministerial Council) develops policy guidance on this matter.  In June 2002, the FSANZ Board granted an extension of six months to the statutory timeframe for the assessment of Application A424.

The Application has been assessed against these Regulatory Principles until the Ministerial Council release fortification policy guidance. The Regulatory Principles were presented at Attachment 2 in the Draft Assessment Report and can be found on the FSANZ website[2]. An extract from these Regulatory Principles that addresses voluntary fortification only is given at Attachment 4. However, a summary of the Regulatory Principles that relate to voluntary fortification is outlined in the Box below.

The Food Regulation Standing Committee (FRSC) has recently commenced work on new policy guidelines in relation to food fortification on behalf of the Ministerial Council to be released early in 2004.  However, in accordance with the FSANZ Act, this Application has to be assessed within the statutory timeframe and cannot be delayed pending guidance from the Ministerial Council.

5. Relevant Issues

5.1 Assessment of A424 against the Regulatory Principles for voluntary fortification and issues raised by submitters

An assessment of the appropriateness of voluntary fortification in relation to both: the nutrient, calcium; and the food vehicles proposed for fortification, has been conducted.  An assessment of the nutrient or food as eligible does not guarantee that a permission for the food/nutrient combination will be granted, but allows the food/nutrient combination to be considered further.

5.1.1 Eligibility of calcium for potential fortification

FSANZ’s Regulatory Principles state that a vitamin or mineral may be considered to be eligible for voluntary fortification in a new food category if more than 30% of more than one age/sex population subgroup has a customary intake below the United Kingdom EAR as shown by national nutrition surveys. 

Percentages of respondents to the 1995 Australian National Nutrition Survey and the 1997 New Zealand National Nutrition Survey with calcium intakes below the UK EAR for calcium were determined. There were a number of population subgroups with 30% or more of respondents whose calcium intake in one day was below the EAR for calcium. In Australia, more than 30% of the respondents from nine subgroups consumed less than the EAR for calcium as assessed by one-day intakes. In New Zealand, more than 30% of the respondents for eight subgroups consumed less than the UK EAR for calcium (only respondents 15 years and over were surveyed). For New Zealand, 33.9% of all respondents consumed less than the EAR.  For Australia, 28.4% of all respondents consumed less than the EAR. This percentage was reduced to 18.8% when adjusted for second-day intakes.

Second-day adjustments are not currently available for subgroups or for the New Zealand population. It is likely that with adjustment for second day intakes, the number of affected subgroups would decline.

However, some subgroups have a much greater than 30% of respondents with one-day intakes below the EAR e.g. 16-18 year old females would likely still meet the Regulatory Principles criterion after adjustment for second-day intakes. Many Maori subgroups also have a high percentage of respondents with intakes below the EAR (see Attachment 2 for data on further subgroups).

Table 1: Percentage of respondents in Australia and New Zealand with dietary calcium intakes below the United Kingdom EAR for calcium (mg/day)

Note. Bold text in each table indicates those groups where greater than 30% of respondents have intakes less than the EAR based on one-day intake.

In its report titled The Burden of Brittle Bones, Access Economics reports that in 2001, nearly two million Australians had osteoporosis-related conditions. Osteoporosis is a multi-factorial disease with calcium intake being one relevant factor.  Although population-based approaches such as fortification are not considered an efficacious method for reducing population incidence of osteoporosis[4], increasing the calcium intake of the population is consistent with national dietary guidance and has the potential to improve currently inadequate calcium intakes. The Australian Dietary Guidelines for Children and Adolescents[5] include a guideline that recommends the consumption of milks, yoghurts, cheeses and/or alternatives, primarily based upon the calcium provided by these products..

The New Zealand Ministry of Health Outcome Targets[6] include increase the intake of calcium so that 75% or more of the population have a calcium intake greater than 600mg per day.

5.1.1.1 Conclusion

Calcium is eligible for further consideration of voluntary fortification (in terms of a risk assessment framework) since:

                more than 30% of more than one age/sex population subgroup has a customary intake below the EAR as shown by national nutrition surveys; and

                calcium intake is one of several factors associated with osteoporosis, a disease of public health significance.

5.1.2 Eligibility of foods for potential fortification

The risk of nutritional inappropriateness of a food to contain, and be promoted as containing, an added vitamin or mineral should be evaluated against the potential for that addition to decrease the percentage of the identified population whose intakes are assessed as inadequate.  In general terms, the food proposed for fortification should be consistent with nationally endorsed guidance for healthy eating. 

Six categories of foods are proposed for calcium fortification; they comprise some non-dairy beverages, soups and most savoury biscuits.  Some of the beverages under consideration contain reasonably high amounts of sugar from both natural and added sources.  While juices contain mainly natural sugars, fruit drinks often contain added sugars.  The dietary guidelines recommend taking care to: consume only moderate amounts of sugars and foods containing added sugars; limit saturated fat and moderate total fat intake; and choose foods low in salt[7],[8].  The products under consideration mostly contain low to moderate amounts of fat, and are generally low in salt with the exception of some soups and vegetable juices. 

5.1.2.1  Assessment of candidate foods against compositional criteria

The compositional criteria for assessing the suitability of a food to be voluntarily fortified is based on a similar approach to that applied to ‘claimable foods’ as defined in Standard 1.3.2.  The compositional criteria to be applied to candidate foods for voluntary fortification are included in the Box in Section 4.2 of this Report.

The majority of candidate foods in the two new food categories to be listed in the Standard i.e. vegetable drinks and soups must meet all of the compositional criteria in order to be eligible for fortification.  The limits on sugar and fat given in these criteria are recipe based, that is, they are stated in terms of added sugars and type of fat ingredients.  This contrasts with the alternate nutrient content approach, in which the total sugars or fat content are determined by nutrient analysis, but which include naturally present sugars and fats.  The foods in the food categories must contain less than 800 mg sodium per serve.  A moderate nutrient density of the food is assured by the requirement that the food contains, per manufacturer’s serve, at least one vitamin or mineral at 5% of the RDI prior to fortification.

FSANZ recognises that not every product in a particular food category would necessarily meet the compositional criteria.  However, permission for voluntary fortification of a food category would be granted (subject to a risk assessment) if the majority of products in that category met all the criteria.  Thus, FSANZ recognises that most:

1.              Savoury biscuits in the category under consideration will meet criteria c), i.e. they will naturally contain at least 5% RDI for at least one vitamin or mineral per manufacturer’s serve size e.g. niacin and/or thiamin and/or phosphorus and/or iron;
2.              Soups will meet criteria b), i.e. they will contain less than 800 mg sodium per manufacturer’s serve size;
3.              Fruit-and vegetable-based beverages will meet criteria a), i.e. they will contain no more than 25% combined added sugars and fat by ingoing weight when prepared according to directions; and
4.              Fruit-and vegetable based beverages will meet criteria c), i.e. they will naturally contain at least 5% RDI for at least one vitamin or mineral per manufacturer’s serve size due to their natural vitamin C or carotene content. 

One submitter to the Initial Assessment Report contended that savoury biscuits are inappropriate foods to contain added calcium because they ‘often have a high fat content’.  However, the Application sought only to extend by one the present range of nine vitamins and minerals permitted addition to savoury biscuits.  Savoury biscuits are already restricted by limits on their fat and sugar content, (not more than 200 g/kg fat and not more than 50 g/kg sugar).  However, in accordance with the Regulatory Principles, the 5% limit for sugar has been expanded to include all sugars as defined in Standard 2.8.1 – Sugars and the drafting at Attachment 1 reflects this.

5.1.2.2 Conclusion

Fruit- and vegetable juices, fruit- and vegetable drinks containing at least 25% juice, soups and savoury biscuits, subject to a risk assessment, are all considered to be eligible food categories for voluntary fortification based on the criteria established in FSANZ’s Regulatory Principles.

5.2 Assessment of the public health risk of permitting calcium fortification of the requested products, incorporating issues raised by submitters

An assessment of the risk of health hazards due to essential nutrient excesses, deficits or imbalances has been conducted in accordance with the following Guiding Statement that has been incorporated into the Regulatory Principles:

Consistent with the Codex General Principles for the Addition of Essential Nutrients to Foods, the addition of vitamins and minerals to general purpose and special purpose foods should not be permitted where no adequate nutritional rationale can be provided. 

Regulatory Principles that are elaborated in accordance with this guiding statement aim to prevent the indiscriminate addition of essential nutrients to foods thereby reducing the risk of health hazards due to essential nutrient excesses, deficits or imbalances.

The vast majority of concerns raised by submitters focused on the fortification of fruit-based beverages; very little comment addressed vegetable beverages, soups or savoury biscuits.

5.2.1 Risk of excess calcium intake

The risk to a population or subpopulation of excess consumption of calcium was discussed at length in the Draft Assessment Report.

The Upper Safe Limit (UL) of 2,500 mg calcium/day set by the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes in the United States is based on the critical endpoint of hypercalcaemia and renal insufficiency (milk alkali syndrome, or MAS). Data on MAS was considered adequate to determine an UL for calcium. The Standing Committee judged the UL for calcium to be conservative and that it should be protective for individuals who are particularly susceptible to high calcium intakes, such as those with hypercalcaemia and hyperabsorptive hypercalciuria. Additionally, a number of studies observed that daily calcium intakes of up to 2,500 mg/day would not cause MAS.

The dietary intake assessment conducted at Draft Assessment estimated one-day dietary calcium intakes, which were adjusted to incorporate second-day intakes in an attempt to gain a more accurate estimation of longer-term intakes. The second-day adjustment factor used at Draft Assessment was developed assuming all the products specified in the Application were fortified with calcium.

Cordial has since been withdrawn from the Application, and further dietary intake assessment has been undertaken (Attachment 2). A second-day adjustment factor has not yet been determined to account for the reduced range of foods. However, for the purposes of comparison, the adjustment factor developed at Draft Assessment is considered sufficiently similar to be  used to adjust the estimated one-day dietary intakes derived in this Final Assessment, without cordial.

The dietary intake assessment of the original list of requested foods including cordials each at a maximum amount of 25% RDI calcium /reference quantity, had assumed 100% industry adoption of the sought after permissions.  Results of the adjusted 95th percentile intake for Australian males aged 16-24 years was approximately equal to the UL for calcium (2500 mg/day).  The conclusion was that this represented a minimal risk of excess calcium intake. 

With the withdrawal of cordials from the Application, revised results indicate that males 16-24 years still remain most at risk of excess calcium intake. Table 2 illustrates the effect on estimated calcium intakes after the withdrawal of cordial from the Application and adjusting for longer-term intake.  The estimated adjusted 95th percentile calcium intake is 2345 mg/day, which is below the UL of the group most at risk of excess calcium intake.

Modelling was again done on the assumption of a 100% uptake by industry to fortify. In reality, only a portion of manufacturers would be expected to fortify their products.  Information available (e.g. NNS data) suggests that the pattern of high calcium consumption of young adult males is not continued through the life cycle. No submitters to the Draft Assessment Report commented on the risk of over-consumption. 

Table 2. Estimated 95th percentile dietary intakes of calcium by Australian males aged 16 – 24 years before and after fortification and adjustment for longer-term intake

5.2.1.1 Conclusion

The evidence provided by dietary modelling in the Draft Assessment Report suggested that there would minimal risk of over-consumption of calcium by permitting the fortification of the foods listed in the original Application. Subsequent modelling to reflect the withdrawal of cordial from the Application has further decreased this risk.

5.2.2  Risk of increased consumption of substitute foods

A further risk relates to the potential for inappropriate substitution of a natural source of a key vitamin or mineral by a nutritionally different food fortified with the same key vitamin or mineral based on product similarity or perceived use. An example of this would be consumers drinking fortified juice in place of their usual milk intake. The implications for inappropriate substitution include changes in nutrient intakes other than the vitamin or mineral proposed for addition. 

Concerns have been raised by submitters, particularly from the nutrition/public health sector, that calcium-fortified fruit- and to a lesser extent, vegetable juices and their drink-type counterparts might be used as a substitute for milk, in particular by low income earners and children (food purchased by the parents because the children do not like the taste of milk or dairy products). 

Experience in the USA during the last 15 years has shown that calcium-fortified beverages have gained an approximate 25% market share within a stable fruit-beverage market and that the fortified products are being substituted for unfortified beverages rather than for milk.  FSANZ has conducted database searches over the period in which calcium-fortified juice has been available in the US and has not identified any research that supports concerns about long term substitution or increased fruit or vegetable beverage consumption. 

The beverages proposed by this Application are considered to be sufficiently different in nutrient profile, taste and use from milk and similar dairy products to be considered an ongoing substitute food for these products.  Moreover, it is considered that any habitual substitution of milk for juice would be by those who also preferred the other attributes of juice over milk. 

Milk and dairy products are also consumed for reasons other than their calcium content such as taste, and the suitability of milk with breakfast cereal, in hot beverages and as an ingredient in baked products, sauces and custards.  One submitter undertook independent research to gain an indication of the response of consumers to calcium-fortified beverages if they were available on the Australian market.

The research involved a Newspoll survey of 1200 people, that asked respondents if they would definitely, probably or not purchase calcium-fortified fruit juice, fruit drinks and or fruit based cordials. Approximately 35% of the interviewees reported they would purchase these products. Of those potential purchasers, about 50-60% said they would purchase fortified beverages as a substitute for something else. The majority of purchases made as a substitute would be used to replace non-fortified beverages including fruit juice beverages and soft drinks.  Only about 8% of respondents considering purchasing any fortified beverage thought that they might use them instead of milk or water. This equates to about 1% of all 1200 respondents considering using fortified beverages as a replacement for something other than a non-fortified fruit beverage or soft drink. The Newspoll survey did not address frequency of purchase (one off or ongoing), or the likely consumed amounts. Neither did it ask respondents who indicated that they might use the fortified beverages as a replacement for milk, if they currently consumed milk. It would be reasonable to assume that the small percentage of respondents who said that they would be consuming these products in place of milk or water would not be replacing all of their milk or water intake over the long term.  Figure 1 below details the executive summary of the Newspoll survey.

Figure 1: Executive summary from Newspoll Survey

Both US and UK consumption trends show declining milk consumption, and an increased consumption of fruit juice. There is no evidence to suggest however, that these trends are a result of calcium-fortified beverages being available in these markets. To date there is no evidence of the effect on milk consumption by the current availability of calcium-fortified juices, regulated as dietary supplements in the New Zealand market or of a small range of fruit drinks bearing claims of a good source of calcium through the use of dairy whey ingredients.  

The industry has stated that foods proposed for fortification with calcium are not intended for promotion as substitutes for dairy foods, but are intended to provide an alternative choice, in addition to calcium supplements or other calcium-fortified foods, for those already not consuming sufficient dairy products for whatever reason. 

5.2.3 Risk of nutrient deficits or imbalances resulting from milk substitution

Described below is the dietary modelling that was undertaken in response to submitter concern that a reduction in milk consumption as a result of this Application could lead to compromised zinc and riboflavin intakes. The modelling was based on the worst-case scenario – a 50% reduction in milk consumption. The percentage of respondents below the EARs for riboflavin and zinc discussed below are based on one-day nutrient intakes. One-day intakes tend to exaggerate low and high intakes when compared to longer-term intakes. Therefore, in reality the percentage of respondents below the EAR, and any shifts in the percentages due to a 50% reduction in milk consumption, would not be as exaggerated as the data derived from one-day intakes described below. Some submitters expressed concern that, should substitution of calcium-fortified beverages for milk occur, there would be nutritional implications for certain subgroups of the population. Submitters to the Draft Assessment Report were concerned about the effect of milk substitution on riboflavin and zinc intakes. A complete set of results for girls and women and the effects of the proposed amendments to the Code on zinc and riboflavin intake with a worst-case scenario can be found in Attachment 2. 

5.2.3.1 Riboflavin

Dietary modelling with a worst-case scenario of 50% reduction in milk consumption showed a small decrease in riboflavin intakes for each population subgroup modelled. The group whose riboflavin status would be most compromised by a 50% reduction in milk intake would be Australian females 16-18 years, also the group whose calcium intake is the most inadequate. Currently 24% of this subpopulation have riboflavin intakes less than the EAR, halving milk intake would result in 28% of the population having intakes under the EAR.

5.2.3.2 Zinc

One submitter to the Draft Assessment Report stated that currently, 75% of Australian girls and women did not reach their respective RDI for zinc, and as milk contained four times as much zinc as fruit juice, substitution of milk for calcium-fortified juice could result in even lower zinc intakes.

Dietary modelling has been undertaken to investigate the effects of a 50% reduction in milk consumption on zinc intake. Results indicated that at baseline, Australian girls and women had a lower intake of zinc than their New Zealand counterparts.

Currently, 15.1% of the Australian and 14.6% of the New Zealand populations are not meeting the UK EAR for zinc. A 50% reduction in milk intake would potentially result in 17.9% and 17.1% of the Australian and New Zealand populations respectively not achieving the EAR, an overall population increase of about 3%. The group at most risk of zinc deficiency as a result of halving their milk intake are females 12-15 years. The present 27% of this group not meeting the EAR would increase to 31% thus resulting in additional 4% of this population group not meeting the EAR. The implication of a 50% reduction in milk consumption on zinc intake is not as great in other subgroups.

5.2.3.3 Conclusion

Dietary modelling with a worst-case scenario of a 50 % reduction in milk consumption was undertaken. Results indicated that there would be a small decrease in riboflavin intakes should 50% of milk consumption be substituted. Although milk is an important dietary source of zinc, worst-case scenario modelling showed that a 50% decrease in milk consumption would result in only a modest decrease in average zinc intakes.  The population group most at risk from a 50% decline in milk consumption was girls aged 12-15 years. The groups at least risk of zinc and riboflavin deficiency as a result of halving their milk intake are children 6-12 years. Considering that the scenario modelled is theoretical and very unlikely, and that the data is based on one-day intakes, it can be concluded that the proposed amendments to the Code will have minimal adverse effects on the micronutrient intake of the Australian and New Zealand populations.

The independent Newspoll survey of 1200 Australians provides evidence to support the trends seen overseas that for the most part, calcium-fortified beverages are likely to be used as substitutes for their unfortified counterparts and soft drinks. Drawing from overseas evidence, it is unlikely that calcium-fortified fruit- and vegetable-based beverages would lead to a marked decline in milk or dairy consumption.

5.2.4  Potential for increase in sugar consumption

As a consequence of any permission granted for the addition of calcium to the proposed foods, the products would be permitted to carry ‘content claims’ in accordance with Standard 1.3.2, clause 6.  In general, claims to the effect that a particular food product is a ‘source’ or ‘good source’ of a vitamin or mineral may be made providing a reference quantity of the food contains at least 10% or 25% RDI respectively of the particular vitamin or mineral and that the food is a ‘claimable food’.  Approval of all foods requested in the Application would mean their inclusion in the Table to Clause 3 of Standard 1.3.2 and this action would render them as ‘claimable foods’ as defined in Standard 1.3.2, clause 1.

In addition to submitters’ concerns related to the inappropriate substitution of milk for calcium-fortified beverages discussed above, submitters also raised the possibility of increased consumption of calcium-fortified foods on the basis of a their promotion as a ‘source’ or ‘good source’ of calcium. 

Submitters to both the Initial and Draft Assessment Reports from the public health/nutrition sector indicated their concern that a ‘good source’ claim displayed on the product label of calcium-fortified products could increase the consumption of calcium-fortified beverages.  An increase in consumption of products high in sugar content may have the potential to increase the risk of dental caries and over nutrition in the population. 

5.2.4.1 Dental caries

One submitter to the Initial Assessment Report suggested in relation to the concern regarding dental caries, there is some evidence to suggest that the addition of calcium to juices and drinks, to some extent, counter-balances the destructive effect of sugar and acid content and thus helps protect the teeth against decay.  Submitters to the Draft Assessment Report debated this with referenced evidence indicating that while calcium may help to strengthen teeth, the nature of the sugar content in fruit- and vegetable-based beverages still renders them cariogenic. Additional information was given regarding the effect of acid on teeth, in particular the negative effects of brushing immediately after consumption of acidic beverages.

The Draft Assessment Report raised the issue that fluoride in water and good dental hygiene could protect against increased caries in the event of increased consumption of fruit juices and beverages. Submitters pointed out however, that not all Australian and New Zealand water is fluoridated, and that dental health has been raised as a key health problem in New Zealand. As calcium-fortified juice is currently available on the New Zealand market, attempts were made to establish the effect that these products have had on the dental health of New Zealanders. However, no data as to the incidence of dental caries, particularly as a result of calcium-fortified juice could be found.  Two dentists were personally contacted: an Associate Professor in dentistry at the University of Otago and a dentist at Auckland Children’s Hospital. They indicated that no data were available to support the contention that availability of fortified juice compared with juice and other acidic beverages in general in the New Zealand market had exacerbated the oral health problems observed in New Zealand.  No submissions from dentists were received in response to either the Initial or Draft Assessment Reports.

The impact of this Application on dental health would be most problematic should the consumption of fruit- and vegetable-based beverages occur in addition to other sugar-based beverages or in place of milk or water.  As discussed previously, this is an unlikely long-term outcome. Two-thirds of the respondents to the aforementioned Newspoll survey stated that they would replace an unfortified beverage by a fortified counterpart (see Figure 1).

5.2.4.2 Over-nutrition

Over-nutrition resulting in an increase in overweight and obesity from consumption of fortified fruit- and vegetable-based beverages is more likely to occur when such beverages are regularly consumed in addition to the usual energy intake or as a substitute for water (or other low energy beverages). Although the energy intake of many consumers exceeds their energy expenditure as judged by the increasing prevalence of overweight and obesity in both countries, a further increase from the additional consumption of fruit- and vegetable-based beverages would require sustained change in dietary patterns to be the cause of increased weight gain.  Fruit juice contains approximately 170 kilojoules/100 g and as such, by volume, is not energy dense compared to many other foods.

The Newspoll results show that very few people (less than 3% of those considering purchase of fortified beverages) would replace water with calcium-fortified beverages (see Figure 1). It is uncertain as to what proportion would consume calcium-fortified beverages in place of their entire water intake.

5.2.4.3 Conclusion

Submitter concerns about increased dental caries resulting from increased sugar intake is warranted, but should not be overstated. The Newspoll survey suggests that the majority of consumers interested in purchasing calcium-fortified fruit- and vegetable-based beverages would do so as a substitute for their unfortified sugar-containing counterparts. Trends observed in New Zealand show no effect of the availability of fortified juice on the dental health of the New Zealand population. Such practices are unlikely to, of themselves, be responsible for further increases in the rates of overweight and obesity in the Australian and New Zealand communities. 

5.2.5 Inappropriateness of juice for infants

Standard 2.9.2 – Foods for Infants regulates foods for infants, and defines them as infants up to 12 months of age. This special purpose standard does not permit the addition of calcium to infant juices, nor is this Standard the focus of the Application.  One submitter to the Initial Assessment Report pointed out that neither undiluted juice nor cow’s milk are appropriate foods for infants.  Submitters to the Draft Assessment Report reiterated this point stating that regardless of infant juice being available on the market, many infants were fed juice that was purchased for consumption by the main household. FSANZ discussed the potential usefulness of an advisory statement to the effect that ‘juice should not be used as a substitute for milk in infant diets’ appearing on fortified beverage labels with health professionals.  Although the majority of them would agree that inappropriate feeding of juice to infants does occur, there were no data that identified the type of juice consumed by infants (fortified or not) to indicate the current extent of this practice in Australia or New Zealand. 

Some consumers expressed concern that the inclusion of a ‘source’ or ‘good source’ content claim for calcium may be misleading if the consumer does not know how much calcium is absorbed and available to be used in the body. Submitters to the Draft Assessment Report were particularly concerned that some consumers may be confused by calcium content claims and therefore inappropriately substitute fortified beverages for milk in the diet of infants and children.

Discussions with New Zealand dietitians on the calcium content claim given on fortified orange juice (dietary supplement) already available on the New Zealand market were held in an attempt to establish  its impact on the purchasing habits of consumers.  The contacted paediatric dietitians were not aware of fortified juice in particular being incorrectly used as an infant or childhood food any more then unfortified juice as a result of calcium content claims. Some submitters argued that calcium-fortified juice would exacerbate failure to thrive and bottle teeth in infants. However, the consulted dietitians commented that milk, particularly when bottle fed, is as much of a problem as juice in its effects on failure to thrive and infant tooth decay.

5.2.5.1 Conclusion

There is anecdotal evidence that children and infants are being inappropriately fed fruit juice and juice-based beverages. However, no data exists to indicate the extent of the problem. Paediatric dietitians contacted in New Zealand were unable to provide any further information on whether the market presence of calcium-fortified juice had increased the prevalence and/or level of its consumption among infants.

5.2.6  Risk of calcium in proposed foods not being bioavailable

In response to the concerns raised regarding bioavailability, this complex issue is influenced by different factors including long term nutrient intake imbalances, nutrient interactions at a single meal and individual variations in the ability to absorb and use various nutrients in the body.  FSANZ recognises that various calcium salts also have different bioavailabilities in different foods.  Recent research has shown that the particular forms of calcium salts suitable for addition to fruit- and vegetable-based beverages is as bioavailable as the calcium in milk, although the effect of calcium-fortified beverages on bone health appears not to be as beneficial as that gained from milk consumption due to intrinsic factors in milk[9].  Decisions as to the suitability of particular chemical forms of vitamins and minerals are made at the time the form is approved for listing in the Code.  The Applicant sought no approval for additional forms of calcium as there are many forms already permitted for use. 

5.2.6.1 Conclusion

Evidence suggests that the suitable forms of calcium for addition to fruit- and vegetable-based beverages are as bioavailable as the calcium in milk, however the Applicant sought no approval for additional forms of calcium.

5.3 Risk Management

5.3.1 Options for risk management

Although the food/nutrient combinations have been assessed as eligible for voluntary fortification in Section 5.1 of this Report, risk management strategies were also considered to address the concerns raised by some submitters, mainly in relation to fruit cordial.  Risk management options for cordial were discussed at length in Section 5.4.1 of the Draft Assessment Report but this section has been amended now that fruit cordial has been withdrawn from the Application.

5.3.2  Labelling statements

In both the Initial and Draft Assessment Reports submitters were invited to comment on the use of an advisory statement to the effect that ‘this food is not a dairy/milk substitute’. Submissions were divided in their opinions of the value or necessity for an advisory statement; all but the dairy industry did not support the advisory statement. The dairy industry suggested a ‘not suitable for children’ statement similar to that for infants and children up to two years of age, which is required on low fat and reduced fat milk products.

Proposal P161 - Review of the declaration of specific labelling statements on packaged food, provides guidance as to the appropriate use of advisory statements.  An advisory statement should be used when:

1.               the general public or the sub-population is exposed to a significant potential risk to health but the risk is not life threatening, or
2.             when guidance about use of a food is needed to protect public health and safety.

Advisory statements hold most value when consumers are prompted to scrutinise food labels, for example when they are at risk of consumption of particular foods due to allergy.  The conclusion from the risk assessment in section 5.2 does not suggest that the risk of substitution of milk for fruit- or vegetable-based beverages, or an increased consumption of fruit- or vegetable-based beverages is of sufficient magnitude to justify an advisory statement.  This information is better suited to nutritional education where the comparative merits of the two products can be fully conveyed. A “not suitable for children” statement is not appropriate because of the absence of intrinsic risk from consumption of calcium-fortified fruit juices as well as the possible inference to purchasers that the statement of unsuitability applies to the juice or drink itself.

Public health submitters to the Draft Assessment Report were also concerned that, at 25% RDI/ 200 mL, a ‘good source’ claim could elevate the image of fruit- and vegetable-based beverages to be the same as milk, which easily qualifies as a good source of calcium.  The natural calcium content of whole milk is about 30% RDI /200 mL and Standard 1.3.2 permits addition of calcium to modified, skim and dried milks to a maximum claim of 40% RDI/ 200 mL Although the proposed variation to the Standard permits a calcium-fortified fruit or vegetable beverage to make a good source of calcium claim, the % RDI shown in the nutritional information panel would be limited to 25% compared with dairy products at higher amounts.  Notwithstanding the prohibition in Standard 1.3.2 on comparative vitamin or mineral claims, the dairy industry has latitude to emphasise to consumers the high calcium content of dairy foods as well as to promote the other nutritional benefits of milk.  The reason for the prohibition on comparative claims for vitamins and minerals is because of the potential for nutritional oversimplification when the nutritional merits of a food focus on only one vitamin or mineral with the consequent potential for consumers to be misled.

5.3.2.1 Conclusion

A statement advising against consumption of calcium-fortified fruit- and vegetable-based beverages is not appropriate because it does not meet the criteria for an advisory statement.  A “not suitable for children” statement is also not appropriate because of the absence of intrinsic risk from consumption of calcium-fortified juices and drinks as well as the possible inference by consumers that the statement of unsuitability applies to the juice or drink itself.  Nutrition education offers more potential to convey relevant messages about the relative nutritional merits of fruit- and vegetable-based beverages and milk.  Although both beverage categories would be permitted to claim their calcium content as a ‘good source’ of calcium, the dairy industry has the opportunity to declare the actual levels of calcium in milk products, which are higher than the maximum claim for fruit- and vegetable-based beverages.

5.3.3 Education

Most submitters from the public health/nutrition sector did not believe that calcium-fortified non-dairy products, particularly cordial, could be readily incorporated into the current nutrition education message.  They also considered that they do not have the resources under a limited budget to reach the culturally and linguistically diverse population that they cover. There is a belief amongst some health and nutrition professionals that fortification will eventually erode the integrity of the food supply and confuse consumers.

A counter argument was put forward by one public health/nutrition professional that these products could readily be included in the nutrition education message.  Milk and dairy products would continue to be promoted as the major source of calcium. 

FSANZ acknowledges that nutrition education has become more complex with the advent of functional foods, use of novel ingredients, and as a result of incremental permissions for voluntary fortification.  The food supply contains several examples where foods contain nutrients and substances with specific health effects that are not intrinsic to those foods, such as high-fibre milk, bread as a source of omega-3 fatty acids, edible oil spreads with phytosterols etc.  Although these products contribute to the increasingly wide variety of for example, milks, breads and edible oil spreads, they usually constitute only a small proportion of the product category.  Nevertheless, the food supply is highly dynamic and manufacturers are sensitive to consumers’ interest in gaining additional health benefits from their food.  There is also a growing level of community interest in consuming nutritional supplements.  As the food supply becomes more complex and ventures outside the traditional nutritional paradigm, public health and nutrition educators are presented with the challenge  to accept the new products as being part of the food supply and to adapt their education message to address the appropriate use of these foods. While the market presence of these products does not change the fundamental message of nutrition education, a significant number of the population are not consuming adequate calcium and there are opportunities to address this nutritional problem through appropriate targeting of the nutrition message.  With these caveats, education is seen as a realistic and effective risk management tool in the context of the appropriate consumption of fortified products.

5.3.3.1    Conclusion

Nutrition education has the scope to address the range of issues for consumers in relation to calcium-fortified beverages including the nutritional merits of all dietary sources of calcium as well as other risks and benefits in the context of current adequate or inadequate calcium intakes. 

5.4  Potential benefits of fortification

5.4.1  Increased calcium intake in some populations

While the effectiveness of voluntary fortification to address a nutritional public health need cannot be assured because any permission is subject to the extent to which industry takes up the permission, an assessment of the potential effectiveness of a food/nutrient combination is also a consideration in deciding whether voluntary fortification will be permitted.  As such, an assessment of the potential dietary impact of calcium in the proposed foods has been conducted and the version that was included in Attachment 4 of the Draft Assessment Report revised.

Currently 28.4% and 33.9% of the Australian and New Zealand populations respectively, do not meet the UK EAR for calcium.  The results after the withdrawal of cordials show that fortification of all the requested foods has the potential to reduce these rates to 20.0% of the Australian and 27.5% of the New Zealand population whose calcium intakes are below the EAR should 100% of industry take up the opportunity to fortify the listed products. Specific populations whose calcium intakes stand to increase from granting the permissions for addition of calcium are: Australian females 11-18 years, which is the population group at greatest risk of not meeting the EAR for calcium.  Adoption of these permissions to the fullest extent could help as many as 20% of those at greatest risk in this population group to meet the EAR ; as well as those who cannot or would not usually eat dairy products.  Further details of the dietary intake assessments revised to reflect the withdrawal of cordials is given at Attachment 2.

5.4.1.1 Conclusion

Although calcium fortification cannot be considered a population strategy to solve the osteoporosis problem observed in Australia and New Zealand, the results of dietary intake assessment show that calcium fortification would help to increase calcium intakes in individuals regularly consuming fortified products.  At best, a 100% uptake by industry of the proposed fortification permissions has the potential to raise to the EAR the calcium intakes of 8% Australians and 6% New Zealand population who do not currently achieve the EAR.

5.4.2 Alternative sources of dietary calcium

Nutritionists often recommend consumption of calcium supplements where calcium intake is possibly not adequate.  Calcium-fortified food products could be recommended as alternative choices to calcium supplements for those with a marginally inadequate calcium intake. New Zealand dietitians commented that young children could not rely on achieving their calcium RDI through consumption of fortified juice or drinks because of the large volume that would need to be consumed.  Although fortified juice and drinks might be an additional source of calcium for those with inadequate calcium intakes, they would still recommend a calcium supplement for those at risk from very low calcium intakes.

5.4.2.1 Conclusion

Although the outcome of permitting fortification of the requested foods would not result in those people who cannot drink milk or eat dairy foods meeting their entire calcium requirements, such products could provide an alternate source of calcium to contribute to the dietary intake.

6. Regulatory Options

There are two options for addressing this Application.

6.1 Option 1 – No approval

Maintain the status quo by not amending the Code to approve the addition of calcium to fruit- and vegetable juices, fruit- and vegetable drinks, soups and savoury biscuits.

6.2 Option 2 – Approval

Amend the Code and approve the addition of calcium to fruit- and vegetable juices, fruit- and vegetable drinks, soups and savoury biscuits.

7. Impacts

Calcium-fortified fruit juices and/or fruit drinks are available in certain countries such as the United States, Germany, France, the Netherlands, the United Kingdom, Finland and Spain.  Calcium-fortified biscuits are available in France, Indonesia, Malaysia, Spain, Taiwan and the United States.  Calcium-fortified soup is available in the United States. Calcium-fortified juices are currently available on the New Zealand market.  These products are currently manufactured to the New Zealand Dietary Supplements Regulations 1985 (NZDSR).  The New Zealand Juice Association in their submission indicated a preference for these products to be regulated as foods rather than as dietary supplements for convenience and ease of enforcement.  Calcium-fortified biscuits are also available on the New Zealand market.

Some fruit drinks have also appeared on the Australian market that carry claims for 25% of the RDI for calcium per 200 mL serving.  The source of calcium is stated as ‘whey minerals or powder’.

7.1 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 other nutrients. 

1.              Public health and nutrition educators and professionals including dietitians and dental educators from both the public and private sector.

1.              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.

                The dairy industry, which currently has a large market share of food sources of calcium.

                The dairy substitute (e.g. soy beverages) industry that currently provides food sources of calcium for those individuals who, for whatever reason, do not consume dairy products.

                The calcium supplement industry that provides an alternative source of calcium for those individuals who, for whatever reason, do not consume dairy products and may provide the calcium salts for fortification of food products.

1.              Governments of New Zealand, the States and Territories and the Commonwealth of Australia including: food regulation enforcement agencies; and the health sector.

7.2 Impact analysis

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.

7.2.1 Option 1: No approval

7.2.1.1 Consumers

                There was no feedback from consumers as to whether they are satisfied with the current range of calcium-containing foods or whether those consumers taking calcium supplements would prefer additional food choices in order to increase their calcium intake. 

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 may be 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. 

Costs

                Through the dietary intake assessment which used data from the 1995 Australian National Nutrition Survey and the 1997 New Zealand National Nutrition Survey, FSANZ has identified some subgroups of the community for which 30% or more of respondents did not meet the EAR for calcium such as: women of most ages; adolescent and older males; and those respondents who did not consume dairy products.  There may be a variety of reasons for this including; vegetarianism, milk allergy, lactose intolerance, or a dislike of milk or dairy products.  Under this option, consumers not meeting the EAR for calcium would not be provided with any additional alternative dietary choices for calcium. 

                Calcium inadequacy is one of several factors that contribute to osteoporosis.  It is difficult to assess the extent to which the consumer incurs the health costs associated with the management of calcium deficiency status should this occur.  In its report on The Burden of Brittle Bones, Access Economics reports that in 2001, nearly two million Australians have osteoporosis related conditions costing A$1.9 billion per annum in health costs and a further A$5.6 billion in indirect costs, representing 1.2% of GDP in 2000-2001 or A$389 for every Australian.  This estimate of the total cost is an increase on the total cost of A$60 million per annum estimated by the Australian Institute of Health and Welfare (AIHW) in 1993-94 which was presented in the Initial Assessment Report. 

7.2.1.2 Public health professionals

Benefits

                The current health/nutrition education messages in relation to obtaining calcium from the diet (and calcium supplements if necessary) are consistent with milk and dairy products being promoted as food sources of calcium. 

Public health educators and nutritionists have argued that it is very important to maintain the consistency of this message in order to avoid consumer confusion over the relevance of milk and dairy products in the diet and retain consistency with nationally endorsed guidelines for healthy eating.

                Additional strategies such as reorienting the health system, creating supportive environments and the development of personal skills have been listed by submitters as necessary for improving the calcium intake of the population.  Some public health/nutrition submitters believe that it is more important to understand the reasons why people are not consuming adequate calcium in order to assist the community to achieve adequate calcium from their diet.

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.  Challenges for nutrition educators in the promotion of calcium-containing foods will remain and continue to increase with the predicted increase of osteoporosis prevalence from two million in 2001 to three million in 2021.

7.2.1.3 Industry

Benefits

                The dairy industry is currently in a strong market position in relation to provision of dietary sources of calcium in both Australia and New Zealand. 

                The advantage to those sectors currently permitted to fortify with calcium, such as breakfast cereals and soy beverages, will remain. 

                Submitters have not identified any other benefits to the industry sector under this option or any other industry sectors that would benefit from this option.

Costs

                There are opportunity costs 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, or the removal of existing foods from the scope of the NZDSR. 

There are costs associated with lack of opportunity for Australian-owned and Australian-based beverage companies currently to sell to the domestic market and to export to international markets.

                It is not known to what extent Australian manufacturers are disadvantaged by the discrepancy between the Australian and New Zealand regulations.

7.2.1.4 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.  The Central Sydney Area Health Services, South Eastern Sydney Area Health Service and the Health Department of Western Australia indicated that there are benefits in maintaining the nutrition education message in order to avoid consumer confusion. They also indicated that they do not have the resources to alter their education message.  Queensland Health also identified a benefit under this option of consistency with the National Health and Medical Research Council (NHMRC) Dietary Guidelines.  Not permitting fortification would help to keep the guidelines simple to follow.

Costs

                Calcium inadequacy is one of several factors that contribute to osteoporosis.  As such, the health costs to governments associated with osteoporosis, as reported by Access Economics in The Burden of Brittle Bones are significant and expected to continue to rise.

7.2.2 Option 2: Approval

7.2.2.1 Consumers

Benefits

Industry groups in support of this Application have indicated that the following benefits would be afforded consumers by allowing the addition of calcium to the requested products:

                Fortification of the proposed products with calcium would provide consumers with additional and/or alternative food sources of calcium.  Submitters have argued that consumers will make use of this additional/alternative source of calcium-containing products in the food supply and some submitters believe that these foods are appropriate to contain added calcium.  This argument is based on: the consumption of some similar calcium-fortified products in the US over a number of years; the stable market for calcium-fortified juices in New Zealand; the number of similar calcium-fortified food products available internationally including soups and biscuits; the use of calcium supplements; and market research. 

                For individuals who have a milk allergy or are lactose intolerant, the availability of calcium-fortified products may provide an alternative food source of calcium to the currently fortified dairy substitutes (e.g. soy beverages). 

                There may be potential to reduce the direct public health costs to consumers that are associated with inadequate calcium intake.  This depends on the degree to which: manufacturers take up the permission; and consumers purchase the fortified foods.  It is estimated that even a conservative 1% reduction in the number of cases of osteoporosis per year may reduce the direct costs of osteoporosis by A$19 million per year.  However, it should be noted that osteoporosis is a complex disease and increasing calcium intake only has a fair probability of improving the disease outcome in target groups or prevention of osteoporosis.

                The Applicant and submitters have indicated that the fortification of the proposed products with calcium will only introduce marginal costs to the manufacturer and that the manufacturer would absorb these costs.  This means that the choice available to consumers would not be denied by prohibitive prices.

Costs

                As indicated by the dietary intake assessment, a large proportion of the population consumes fruit juices and fruit drinks.  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.  The dietary intake assessment has indicated that there is little risk of consumers exceeding the UL for calcium of 2500 mg per day over a long period. 

                Trends in the US and New Zealand (based on overall market share figures) indicate that substitution of calcium-fortified juice or drinks for milk as an alternative calcium source is unlikely to occur. However, should substitution occur in young children, the

                potential exists for symptoms resulting from malabsorption of carbohydrate and dental problems. 

                Consumers may be further confused about which products they should choose as their sources of calcium. 

7.2.2.2 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

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.  Submitters from this sector believed that considerable changes would be required to the nutrition education message to prevent people from substituting calcium-fortified products for more traditional sources, such as dairy products. 

As such, they believed that a substantial amount of information would be required about calcium-fortified products in order to inform the community of the nutritional implications of substituting calcium-fortified foods for milk and dairy products.  They did not believe that they would have the resources to implement these changes to the nutrition education message and reach the culturally and linguistically diverse community that they serve.

• Public health submitters were concerned that a change to the Code as a result of this Application could create a precedent for more applications for permission to fortify a variety of foods, and that the result of permitting fortification would lead to a loss in the integrity of the current food supply.

7.2.2.3 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.  Industry has indicated that the extent to which the voluntary permission is taken up depends on market forces but the US experience of 25% of fruit juice sales being fortified juices could be reproduced in Australia and New Zealand.  Data from the Retail World Grocery Guide (2002) indicate that the biscuits market is A$939 million of which crispbread, rice crackers and crackers contribute 10%, 10% and 8% respectively.  Fruit juice and drinks markets are worth A$738 million; of which 66% is juice and 34% is drink.  The market for soups is worth A$361 million.  It is anticipated that growth in the calcium-fortified citrus juice market would be in the range of 15% market share over the first two years (based on trends seen in the US) should a voluntary permission be granted for these products.  A potential market for calcium-fortified vegetable juice and/or juice products from Australian manufacturers to Singapore in the range of 6-10 million litres for finished product has been identified based on data from the Singapore Juice and Vegetables Data Euromonitor. 

                This option will allow for economies of scale in manufacturing the same products for both domestic and export markets.

                Experience from the US with fortified juices indicates that they are priced similarly to unfortified juices.  With calcium fortification to 25% RDI per serve, the additional cost per serve is expected to be minimal and competitive market pressure will determine final pricing meaning that manufacturers are likely to absorb the additional cost.

                The development of new products for exporters in particular will lead to an expansion of industry production.

                This option will provide Australian manufacturers with the same opportunities as New Zealand manufacturers.  The New Zealand Juice Association has expressed a preference for calcium-fortified juices to be positioned as foods rather than dietary supplements, as is currently the situation.

Costs

                The potential exists for the displacement of milk or calcium-fortified milk substitutes for the proposed products that may disadvantage the milk/dairy and/or milk/dairy substitute industry.  However, this is considered unlikely to occur based on trends in other countries and the food categories proposed for fortification.  The dairy industry is concerned about the potential for loss of market share if a voluntary permission for addition of calcium to the proposed products is granted.  The dairy industry has stated that milk consumption is already declining and this option may encourage further decline.  The Fonterra co-operative group stated that the dairy industry is also a key contributor to the New Zealand economy and this option may pose a further threat.

                Possible disadvantages exist for smaller, locally 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.  This has not been confirmed by submissions whereas on the contrary, all industry sectors with the exception of the dairy industry showed support for this option.

                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.

7.2.2.4 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 as indicated in the Access Economics Report on The Burden of Brittle Bones.

                The Australian Food and Grocery Council (AFGC) has deduced that, if successfully increasing calcium intake through this fortification measure such that 10% fewer people developed osteoporosis, a future health dividend of A$190 million per annum based on year 2000 costs could be anticipated.  Even a conservative 1% reduction delivers A$19 million benefit in direct costs. 

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.  Public health/nutrition educators have indicated that there would be additional costs involved with adjusting the education message in order to inform the culturally and linguistically diverse population about the potential nutritional implications of inappropriate consumption of the products.

                While some submissions were received from government, and most were opposed to granting a voluntary permission, no comments regarding the implications for enforcement associated with this option were received. 

                The potential for increased dental health problems exist however, this is considered to be minimal based on the unlikelihood of substitution of the calcium-fortified products for traditional sources of calcium.

8. Consultation

The Draft Assessment Report for A424 was available for public consultation from 18 December 2002 until 21 February 2003. A total of 25 submissions were received, with 14 of these from Australia, seven from New Zealand and four on behalf of Australia and New Zealand or Australasia.

Of these 25 submitters, 10 unconditionally supported Option 2 (amend the Code as originally requested by the Applicant and approve the addition of calcium to the proposed products), 10 submitters opposed the Application in its entirety (support for Option 1, maintain the status quo), four submitters supported Option 2 for some of the proposed products only, and three submitters expressed the view that this Application should not be assessed in isolation and recommended a comprehensive review of Standard 1.3.2 and the regulatory principles underlying this standard. Of the five submitters who requested a review of Standard 1.3.2, one supported Option 2 and four supported Option 1 in the absence of such a review. A summary of submissions is at Attachment 3.

The Initial Assessment Report for A424 was available for public consultation from 12 December 2001 to 13 February 2002.  A total of 28 submissions were received, with 21 of these from Australia, four from New Zealand and three on behalf of both Australia and New Zealand or Australasia.  Of these 28 submissions, 17 were received from industry sectors, two were from consumer groups, five were from the public health sector and four were from government agencies.  A summary of submissions is at Attachment 5 of the Draft Assessment Report.

8.1 Notification to the World Trade Organization

Australia and New Zealand are members of the WTO and are bound as parties to WTO agreements.  In Australia, an agreement developed by the Council of Australian Governments (COAG) requires States and Territories to be bound as parties to those WTO agreements to which the Commonwealth is a signatory.  Under the Agreement between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards System, FSANZ is required to ensure that food standards are consistent with the obligations of both countries as members of the WTO.

As a member of the World Trade Organization (WTO), Australia and New Zealand are obligated to notify WTO member nations where proposed mandatory regulatory measures are inconsistent with any existing or imminent international standards and the proposed measure may have a significant effect on trade.

Amending the Code to permit the use of calcium in fruit- and vegetable juice, fruit- and vegetable drinks, savoury biscuits and soups is unlikely to have a significant effect on trade. Therefore, notification will not be made to the WTO as a TBT in accordance with the WTO Technical Barrier to Trade (TBT) agreements.

9.  Implementation

Approval of the Application will result in the proposed variation to Standard 1.3.2 commencing on gazettal.

10. Conclusion and Recommendation

FSANZ approves the draft variation to Standard 1.3.2 to permit the voluntary addition of calcium to fruit and/or vegetable juices, fruit and/or vegetable drinks, soups and savoury biscuits to 25% RDI/reference quantity, a level that allows a ‘good source’ content claim, for the following reasons:

                Calcium is considered to be potentially eligible for voluntary fortification because, in accordance with the Regulatory Principles for the addition of vitamins and minerals to foods, 30% of at least one population subgroup in both Australia and New Zealand has a customary intake below the Estimated Average Requirement (EAR) based on National Nutrition Surveys.

                All the foods requested by the Applicant are considered to be eligible for voluntary fortification since the food categories generally are consistent with FSANZ’s Regulatory Principles.

                The dietary intake assessment estimates that there would be negligible risk of excess calcium intake based on the addition of calcium at the levels requested assuming 100% uptake of the permission for all the proposed foods. Overseas experience indicates that there is minimal risk of long-term substitution of calcium-fortified beverages for milk, or an increase in consumption of such calcium-fortified beverages on the basis of the approvals contained in this Report.

                The addition of calcium to all the proposed foods has the potential to increase the calcium intake for the population or subgroups of the population with a current intake assessed as inadequate.  However, this potential benefit depends on the extent to which this voluntary permission is taken up by industry.

                A permission for voluntary fortification of the proposed foods with calcium would provide consumers with additional and/or alternative food sources of calcium.

The proposed drafting for of the Code is at Attachment 1 of this Final Assessment Report.

Attachments

1.              Draft variation to the Australia New Zealand Food Standards Code

1.              Dietary assessment

1.              Summary of Submissions

1.              Regulatory Principles for the addition of vitamins and minerals to foods

ATTACHMENT 1

DRAFT VARIATION TO THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE

To commence: on gazettal

[1] Standard 1.3.2 of the Australia New Zealand Food Standards Code is varied by –

[1.1] omitting from the Table to clause 3, the entry for Biscuits containing not more than 200 g/kg fat and not more than 50 g/kg sugar, substituting -

[1.2] inserting in the Table to clause 3, Columns 3 and 4, under the entry for Fruit juice, reconstituted fruit juice, concentrated fruit juice –

[1.3] inserting in the Table to clause 3, Columns 3 and 4, under the entry for Tomato juice, concentrated tomato juice –

[1.4] inserting in the Table to clause 3, Columns 3 and 4, under the entry for Vegetable juice –

[1.5] omitting from the Table to clause 3, the entry for Fruit drinks containing at least 250 mL/L of the juice, puree of 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, substituting -

[1.6] inserting in the Table to clause 3  -

ATTACHMENT 2

DIETARY INTAKE ASSESSMENT

A 424 – Addition of calcium to fruit- and vegetable juices, fruit- and vegetable drinks, soups and savoury biscuits

Summary

A dietary intake assessment was considered necessary to determine the potential impact of the fortification of the proposed 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 investigated the risk to consumers with high calcium intakes exceeding the Upper Safe Limit (UL) and the potential effectiveness of fortification of the proposed foods with calcium.

Data from national nutrition surveys show a sizable portion of the population in Australia and New Zealand do not obtain adequate calcium intakes from their food consumption habits and the naturally occurring calcium content of foods and the small amount of existing calcium fortification. Particular population groups with low calcium intakes include adolescent and adult females in Australia and New Zealand, New Zealand Maori, Australians of Asian ethnicity and non-dairy consumers in Australia and New Zealand. 

It is considered unlikely that high consumers of calcium will exceed the UL for calcium from the diet alone on a long-term basis. Fortification of the products proposed in this Application with calcium has the potential to increase the calcium intake of the population groups identified as being potentially at risk of inadequate calcium intake. However, there may still be some groups not meeting their calcium requirements, even after fortification. 

Dietary modelling indicates that fortification of the products proposed in this Application would have minimal adverse impact on the intake of various micronutrients found in milk, should milk be substituted by calcium-fortified beverages.

Background

The Applicant is seeking a voluntary permission for calcium to be added to fruit - and vegetable juices, fruit – and vegetable drinks, soups and savoury biscuits to provide alternative sources of calcium in the diet, particularly to population groups that may be at risk of inadequate dietary calcium intake. The requested level of addition of calcium to these products would provide not more than 25% of the Recommended Dietary Intake (RDI) of calcium per reference quantity.

Since the Draft Assessment, cordial has been withdrawn from the Application. The dietary modelling conducted at Draft Assessment has been repeated with adjustments to reflect the withdrawal of cordial. In addition, submitters to the Draft Assessment Report commented on the potential substitution of milk by calcium-fortified beverages. A submission raised specific concern about the effect of substitution on zinc and riboflavin intakes for particular age and sex groups of the population. Dietary modelling was conducted to estimate the effect of substituting milk consumption with calcium-fortified beverages. 

Dietary Intake Assessment by FSANZ

Dietary modelling was conducted by FSANZ to estimate potential dietary intakes of calcium for Australia and New Zealand when a number of foods are fortified with calcium. The intake assessments include calcium intake from other sources in the diet, but not from supplements. Information on calcium intake from supplements was not available to be included in the dietary intake assessment.

The dietary intake assessment was conducted using dietary modelling techniques that combine food consumption data with nutrient content data, developed for the respective 1995 and 1997 National Nutrition Surveys (NNSs), to estimate the intake of the nutrient from the diet. The dietary intake assessment was conducted using FSANZ’s dietary modelling computer program, DIAMOND.

Dietary intake = food nutrient concentration x food consumption

The potential dietary intake of calcium from fortification of the proposed products with calcium was estimated by combining:

                usual patterns of food consumption, as derived from the NNS data; and

                the existing levels of calcium in foods and the levels of calcium proposed by the Applicant for the particular products.

Dietary Survey Data

DIAMOND contains dietary survey data for both Australia and New Zealand; the 1995 NNS from Australia that surveyed 13 858 people aged 2 years and above, and the 1997 New Zealand NNS that surveyed 4 636 people aged 15 years and above. Both surveys used a 24-hour food recall methodology to collect food consumption data.

Assumptions made in the dietary intake assessment

Assumptions made in the dietary intake assessment include:

                all the foods within the group contain calcium at the specified/proposed levels, unless stated otherwise;

                all consumers of foods from the food groups to be fortified consume the fortified version;

                consumption of foods are actual amounts as recorded in the NNSs; and

                calcium contained in foods is 100% available (no distinction is made between the bioavailability of calcium that occurs naturally in foods and calcium salts used for fortification).

Limitations of the dietary intake assessment

A limitation of estimating dietary intake over a period of time associated with the dietary modelling is that only 24-hour dietary survey data were available, and these tend to over-estimate habitual food consumption amounts for high consumers. Therefore, predicted high percentile intakes are likely to be higher than actual high percentile intakes over a lifetime.

A second 24-hour recall was conducted on a subset of the respondents to each NNS. Together with the Australian Bureau of Statistics (ABS), FSANZ has recently developed a procedure to account for second day nutrient intakes by the use of factors that adjust the first day intake to gain a more accurate estimation of longer-term nutrient intakes. At present this approach is adopted only for Australia and adjustment factors have been determined for only a limited number of scenarios. The dietary modelling conducted at Draft Assessment incorporated second day adjustment factors for the total population group (before and after calcium fortification) and males aged 16 to 24 years age group (after fortification only) for Australia.

Cordial was withdrawn from the Application after Draft Assessment, however a second-day adjustment factor to reflect this withdrawal has not yet been developed. For the purpose of comparison however, the adjustment factor developed for the male 16-24 years age group at Draft Assessment was considered suitable to adjust the revised one-day dietary intakes derived in this Final Assessment for the same age group. Second day adjustments will have no impact on estimated mean calcium intakes, but would likely reduce estimated high calcium intakes and increase low one-day intakes. 

FSANZ’s dietary intake assessment does not take into account calcium intake from mineral supplements.

Estimating the Risk of Excess Calcium Intake

In order to determine if the level of intake of calcium will be of public health and/or safety concern, the estimated dietary intakes were compared to an UL of intake. Australia and New Zealand have not set an UL for calcium, but the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes in the United States has set an UL of 2.5 g calcium/person/day. In this report an UL of 2.5 g calcium/person/day was used.

Dietary Intake Assessment provided by the Applicant

The Applicant highlighted the importance of adequate calcium intakes for the whole population. Data from the 1995 Australian National Nutrition Survey (NNS) and the 1997 New Zealand NNS were provided, detailing calcium intakes and food consumption for the Australian and New Zealand populations. Data on median calcium intakes indicated that all male age groups met their RDI, except males over the age of 45 years that had a calcium intake just under the relevant RDI, whereas females generally did not have adequate calcium intakes in relation to their respective RDIs. Data on the percentage of foods consumed by various age groups in the population indicates that a very high proportion of Australians consume milk and milk products, the major source of calcium in the diet, yet there are still some groups with inadequate calcium intakes.

The Application did not provide estimated calcium intakes of the at risk groups outlined, assuming fortification of the proposed products.

Assessing the Eligibility and Potential Effectiveness of Calcium Fortification

FSANZ’s Regulatory Principles state that a vitamin or mineral may be considered to be eligible for voluntary fortification if more than 30% of more than one age/sex population subgroup has a customary intake below the United Kingdom Estimated Average Requirements (EARs) as shown by national nutrition surveys. 

Survey data were analysed to determine if more than 30% of any population subgroups had customary calcium intakes below the EAR. Modelling was also conducted to assess whether fortification of the products specified in the Application might increase calcium intakes in subgroups with low calcium intakes. Estimated dietary calcium intakes before and after fortification were compared to EARs for calcium. The EARs vary depending on age and sex. The age and sex groups and their respective EARs included in the dietary modelling are shown in Table 1. 

Table 1. Population groups included in dietary modelling and their respective EARs

Scenarios for dietary modelling

The dietary intake assessment for calcium was conducted for both Australian and New Zealand populations and compared to EARs for the age groups shown in Table 1.

Dietary modelling was also conducted for the following population groups considered to be at risk of low calcium intakes:

                New Zealand Maori (New Zealand only);

                People of Asian ethnicity[10] (Australia only); and

                Non-dairy consumers[11] (Australia and New Zealand).

These population groups were modelled using the same age groups listed in Table 1. 

Potential changes in consumption patterns were explored previously at Initial Assessment. The model assumed that parents allow children (6-12 years) to substitute calcium-fortified beverages for milk as a drink and source of calcium.

The potential impact on the intake of calcium and other nutrients found in significant quantities in milk (protein, vitamin A and riboflavin) as a result of this substitution was investigated. It was assumed that there would be a 50% decrease in milk consumption as a result of substitution. 

This scenario was adjusted for the Final Assessment Report to estimate the effect of a 50% reduction in milk consumption on the zinc and riboflavin intakes of population groups highlighted by submitters to the Draft Assessment Report as already being at risk of low zinc and riboflavin intakes. The age groups identified were teenage girls and women. Children aged 6-12 years were also included in this scenario. The UK EARs for zinc and riboflavin are shown below in Table 2.

Table 2. United Kingdom EARs for zinc and riboflavin

Calcium Concentration levels

The levels of calcium fortification in foods used in the models were derived from information provided by the Applicant on serve sizes and the RDI. The Applicant proposes to fortify products to a level so that one reference quantity will provide no more than 25% of the RDI for calcium. The RDI assumed in calculating the modelling concentration levels was 800 mg. Although there are varying RDIs for different age and sex groups in the population, an RDI of 800 mg was used for this purpose, as this is the general RDI referred to in Standard 1.3.2 - Vitamins and Minerals of the Australia New Zealand Food Standards Code. The reference quantities were provided by the Applicant and are 200 mL for fruit - and vegetable juices and drinks, 200 mL for soups and 35 g for savoury biscuits. These are based on the reference quantities specified in Standard 1.3.2. The foods and proposed levels of fortification are shown below in Table 3.

Table 3: Proposed fortification levels of calcium in foods

* For dietary modelling purposes, 100 g is assumed to be equivalent to 100 mL for beverages.

How were the dietary intakes calculated?

The DIAMOND program contains existing levels of calcium in foods as determined in the 1995 Australian NNS or 1997 New Zealand NNS and also allows scenario calcium concentrations to be assigned to food groups. Scenario calcium concentrations were applied to fruit - and vegetable juices, fruit – and vegetable drinks, soups and savoury biscuits (less than 200 g/kg of fat).

The DIAMOND program multiplies the specified concentration of calcium by the amount of food that an individual consumed in order to estimate the intake of calcium from each food. Once this has been completed for all of the foods containing calcium, the total amount of calcium consumed from all foods is summed for each individual. Population statistics (mean and high percentile intakes) are then derived from the individuals’ ranked intakes.

Results

The percentages of respondents, from various population subgroups, with estimated pre- and post-fortification calcium intakes below the EAR are described below. This data is presented in more detail in Table 7 to Table 12 in the Appendix to this attachment. Population groups with greater than 30% of respondents having a calcium intake less than the EAR are highlighted in these tables (appearing in bold font in each table).

Pre-fortification calcium intake

Adequacy of calcium intake

General population

The number of respondents with an estimated calcium intake below the EAR was generally higher for females than males. Females aged 16-18 years had the greatest percentage of respondents below the EAR for Australia (47%). Females aged 13-15 years also had over 40% of respondents below the EAR. All other Australian female age groups over the age of 10 years had greater than 30% of respondents below the EAR (Table 7).

The greatest percentage of Australian male respondents with an estimated calcium intake below the EAR came from the 11-12 years age group (37%). Males aged 13-15 years also had greater than 30% of respondents below the EAR, while males aged 16-18 years had 30% of respondents below the EAR. Young children (less than 11 years) had the lowest percentage of respondents with calcium intakes below the EAR for Australia.

The total Australian population had 28% of respondents with estimated calcium intakes below the EAR. However, when adjustments were made to account for second day intakes, this level was reduced to 19% of respondents below the EAR for calcium. 

For New Zealand, males aged 15-18 years had the highest percentage of respondents (44%) with estimated calcium intakes below the EAR. All other New Zealand age and gender groups had over 30% of respondents with estimated calcium intakes below the EAR, with the exception of males aged 19-24 years (28%) and 25-44 years (22%). The total New Zealand population had 34% of respondents with estimated calcium intakes below the EAR. Second day adjustment factors are not currently developed for New Zealand data.

New Zealand Maori

Just over 40% of all New Zealand Maori respondents had an estimated calcium intakes below the EAR. Males aged 25-44 years was the only group to have less than 30% of respondents with an estimated calcium intake below the EAR. The other population groups ranged from 39% (females 25-44 years) to 63% (females aged 65 years and over) of respondents with estimated calcium intakes below the EAR (Table 9).

Australians of Asian ethnicity

Almost 42% of the total number of respondents of Asian ethnicity had estimated calcium intakes below the EAR. A number of age groups had over 60% of respondents with an estimated calcium intake below the EAR, including females aged 13-15 years, 16-18 years and 65 years and over. Only children (10 years or younger) had less than 30% of respondents below the EAR for calcium (Table 10).

Non-dairy consumers

The percentage of non-dairy consumers below the EAR was much higher for each population sub group and for the total population in both Australia and New Zealand. Over 80% of total respondents who reported not consuming dairy products had estimated calcium intakes below the EAR for both countries (Table 11).

These results show that a large number of population groups do not get adequate calcium intakes from their food consumption habits and the naturally occurring calcium content of foods.

Risk of Excess Calcium Intake

The greatest estimated 95th percentile calcium intake was for the male 16-24 years age group in Australia (2460 mg). This level of intake is just below the UL of 2500 mg/day and is unadjusted for second-day nutrient intake. If the adjustment factor developed for this age group at Draft Assessment is applied, this estimated intake is reduced to 2105 mg/day. Although this adjustment factor was developed for a slightly different scenario (calcium fortification of the originally requested foods), it is likely to be very similar to a factor developed for the pre-fortification calcium intake reported here. 

Post-fortification calcium intake

Increase in proportion of calcium adequacy

General population

Fortification of the proposed products (now excluding cordial) reduced the percentage of respondents with estimated calcium intakes below the EAR for calcium. New Zealand males aged 15-18 years had the greatest percentage of respondents with a post-fortification calcium intake less than the EAR (37%). Other population groups with more than 30% of respondents below the EAR after fortification were New Zealand females aged 15-18, 19-24, 25-44 and 65+ years, and Australian females aged 16-18 years.

However, the percentage of respondents with estimated calcium intakes below the EAR for Australian females aged 16-18 years, fell from 47% before fortification to 30% assuming the proposed foods are fortified and all respondents consumed the fortified version of the food. Similar reductions were experienced for most age/gender groups for Australia and New Zealand after fortification (Table 8).

The percentage of total respondents with an estimated post-fortification calcium intake below the EAR was 20% and 28% for Australia and New Zealand respectively. These levels are approximately 8% and 6% lower than pre-fortification estimates for Australia and New Zealand respectively.

New Zealand Maori

If the proposed products were fortified, almost 36% of all New Zealand Maori respondents had an estimated calcium intake below the EAR, compared to 40% before fortification. Although all age and gender groups had a reduced percentage of respondents below the EAR after fortification, only two groups had less than 30% of respondents below the EAR for calcium (males aged 19-24 years and 25-44 years). Males and females aged 65 years and over still had 50% and 58% of respondents respectively, with estimated post-fortification intakes below the EAR for calcium (Table 9).

Australians of Asian ethnicity

The percentage of Asian respondents with estimated post-fortification calcium intakes less than the EAR was 30%, compared to almost 42% before fortification. Most age and sex groups had similar reductions, however, females aged 65 years and over still had 57% of respondents with estimated calcium intakes below the EAR (Table 10).

Non-dairy consumers

Fortification of the proposed products reduced the number of respondents with an estimated calcium intake below the EAR for non-dairy consumers in Australia and New Zealand. The percentage of respondents with estimated post-fortification calcium intakes below the EAR for the total population of Australia was 60%, compared to 81% before fortification. The reduction was not as large for the total New Zealand population, falling from 86% to 73% after fortification. Only three population groups for Australia and New Zealand (Australian males and females 2-3 years and males 7-10 years) had fewer than 30% of respondents below the EAR after fortification (Tables 11 and 12).

Although the number of respondents in some of the age and sex groups of the Asian and non-dairy consumers scenarios was quite small, particularly for children, the results for these age and gender groups generally followed the trend of the total population with younger children having a lower proportion of respondents below the EAR than adolescents and adults.

In general, these results show that when the proposed foods are fortified with calcium, intakes of calcium may increase and there would be fewer people not meeting their calcium requirement. However, there may still be some groups of the population with large numbers of respondents not meeting their requirements, even with maximal uptake of the permission to fortify.

Risk of excess calcium intake

The dietary intake assessment for the Initial Assessment Report highlighted the potential for the 95th percentile calcium intake of males aged 15-24 years to exceed the UL for calcium if all the proposed products were fortified with calcium. The estimated 95th percentile calcium intake for this population group, based on one day unadjusted intakes, was 3080 mg/day. 

At Draft Assessment the estimated one-day intake was adjusted to take into account the effect of second day intakes. The second day adjustment factor determined by the ABS applies to the 16-24 years age group, so this was the age group included in the dietary modelling at Draft Assessment.

The withdrawal of cordial from the Application after Draft Assessment had the effect of lowering the estimated high intakes of calcium by young adult males. The adjusted estimated 95th percentile calcium intake is reduced below the UL for calcium (to 2345 mg/day) with calcium-fortified cordial removed from the modelling. Although the second-day adjustment factor used was developed while cordial was still included in the Application, the withdrawal of cordial is likely to have only a very small effect on this factor, and hence on the adjusted values presented above.

These results are summarised in the following Table 4.

Table 4. Estimated 95th percentile dietary intakes of calcium by Australian males aged 16 – 24 years before and after fortification and adjustment for longer-term intake

These results indicate that fortification of the proposed foods will not result in high intakes that may be of a public safety concern for any population or population sub-group.

Half-substitution of milk with calcium-fortified beverages

Before milk consumption was reduced by 50% the population group with the greatest percentage of respondents with riboflavin intakes below the EAR was females aged 16-18 years (24.3%). If milk consumption was reduced by 50% the same age group still had the greatest percentage of respondents below the EAR for riboflavin, at 27.5%. Children aged 6‑12 years had the lowest percentage of respondents with riboflavin intakes below the EAR before and after milk substitution.

Females aged 12-15 years had the greatest percentage of respondents with estimated zinc intakes below the EAR before a reduction in milk consumption (27.3%). This percentage increased to 30.6% when it was assumed there was a 50% reduction in milk consumption as a result of the substitution of milk with calcium-fortified beverages.  Females aged 65 years and over had similar, although slightly lower percentages of respondents below the EAR. New Zealand females aged 16-18 years had the lowest percentage of respondents below the EAR at baseline (12.6%) and after substitution of milk (14.7%).

Table 5. Percentage of respondents in Australia with intakes below the United Kingdom EARs for zinc and riboflavin before and after milk substitution

Table 6. Percentage of respondents in New Zealand with intakes below the United Kingdom EARs for zinc and riboflavin before and after milk substitution

Modelling presented previously at Initial and Draft Assessment

Potential changes in consumption patterns were explored previously at Initial Assessment. The model assumed that parents allow children (6-12 years) to substitute calcium-fortified fruit cordial for milk as a drink and source of calcium. The potential impact on the intake of calcium and other nutrients found in significant quantities in milk (protein, vitamin A and riboflavin) as a result of this substitution was investigated. It was assumed that there would be a 50% decrease in milk consumption, substituted by a 50% increase in calcium-fortified fruit cordial consumption. It was assumed that other products specified in the Application were not fortified with calcium. Modelling could only be undertaken with Australian data.

Before this substitution scenario, children aged 6-12 years had estimated mean protein, vitamin A and riboflavin intakes greater than their respective RDIs[12] (288%, 195% and 165% respectively). Based on the substitution modelling above, the estimated mean intakes of protein, vitamin A and riboflavin were all slightly lower, but still greater than their respective RDIs (268%, 180%, and 142% respectively). Not further dietary modelling was undertaken based on this model at Draft Assessment.

At Draft Assessment a fortification scenario was conducted in an attempt to make a more realistic estimate based on experience in the US market, where 25% of the fruit and vegetable juice market contains calcium-fortified juices. Therefore, for this scenario it was assumed that 25% of fruit and vegetable juices would be fortified, rather than all fruit and vegetable juices as is assumed in the other fortification scenarios.

The percentages of all respondents to each NNS in Australia and New Zealand below the EAR for calcium were only slightly higher (2%) than the original scenario assuming all fruit and vegetable juices were fortified, and were 8% and 7% less than the percentage of respondents with pre-fortification calcium intakes below the EAR. The effect of this scenario on the estimated post-fortification intake of high consumers was small. It is likely that very similar results would be obtained if cordial were deleted from the modelling.

Conclusion

Data from the 1995 Australian and 1997 New Zealand National Nutrition Surveys indicates that a number of population groups are potentially at risk of having dietary calcium intakes below the EAR for calcium in Australia and New Zealand from the general diet. The proportion of adolescent and adult females with estimated calcium intakes below the EAR for calcium is generally higher than for young children and males. Other population groups, such as New Zealand Maori, Australians of Asian ethnicity and particularly non-dairy consumers have a large proportion of people with estimated calcium intakes below the EAR. 

Fortification with calcium of the products proposed in this Application has the potential to increase the calcium intake of the population groups identified as being potentially at risk of inadequate calcium intake and thereby reduce the number of people with calcium intakes below the EAR for calcium. 

The adjusted post-fortification intakes of Australian males aged 16-24 years presented in the Draft Assessment Report resulted in an estimate of high calcium intake that was lower than that based solely on one-day intake. The adjusted 95th percentile calcium intake was very close to the UL.  The withdrawal of cordial from the Application reduced the adjusted estimate of 95th percentile intake of calcium after fortification to 2345 mg/day. It is considered unlikely that the UL would be exceeded from the diet alone on a long-term basis given the conservative nature of modelling assumptions.

Dietary modelling indicates that fortification of the products proposed in this Application would have minimal adverse effects on the intake of various micronutrients found in milk should 50% of milk consumption be substituted by calcium-fortified beverages.

The estimated calcium intakes presented above do not include calcium intakes from supplements. As no data are available on calcium intakes from supplements, it is difficult to determine what impact supplement intake may have.

Appendix

Table 7: Percentage of respondents in Australia and New Zealand with intakes below the United Kingdom EAR for calcium before fortification

Note. Bold text in all tables indicates those groups where greater than 30% of respondents have intakes less than the EAR.

Table 8. Percentage of respondents in Australia and New Zealand with intakes below the United Kingdom EAR for calcium after fortification*

*Assuming all proposed products (now excluding cordial) in the Application are fortified with calcium.

Table 9. Percentage of Maori respondents in New Zealand with intakes below the United Kingdom EAR for calcium before and after fortification*

*Assuming all proposed products in the Application (now excluding cordial) are fortified with calcium.

Table 10. Percentage of respondents of Asian ethnicity+ in Australia with intakes below the United Kingdom EAR for calcium before and after fortification*

+ Born in an Asian country and living in Australia at the time of the 1995 National Nutrition Survey.

*Assuming all proposed products in the Application (now excluding cordial) are fortified with calcium.

Table 11: Percentage of non-dairy consuming respondents in Australia and New Zealand with intakes below the United Kingdom EAR for calcium before fortification

Table 12: Percentage of non-dairy consuming respondents in Australia and New Zealand with intakes below the United Kingdom EAR for calcium after fortification*

*Assuming all proposed products in the Application (now excluding cordial) are fortified with calcium.

ATTACHMENT 3

SUMMARY OF SUBMISSIONS

ATTACHMENT 4

REGULATORY PRINCIPLES FOR ADDITION OF VITAMINS AND MINERALS TO FOODS

Introduction

During the 1990s and into this decade, the predecessors of Food Standards Australia New Zealand (FSANZ) have developed regulatory principles as required to guide decisions in relation to the addition of vitamins and minerals to categories of foods such as: general purpose foods; and special purpose foods.  Permissions for addition of vitamins and minerals to foods are given in Standard 1.3.2 (general purpose foods), in each of the standards contained in Part 2.9 (special purpose foods) of the Food Standards Code.

The regulatory principles for addition of vitamins and minerals to general purpose and special purpose foods are based to some extent on the Codex General Principles for the Addition of Essential Nutrients to Foods (Codex General Principles) developed by the Codex Alimentarius Commission.  The Codex General Principles embody the concepts of risk and effectiveness and are based on sound nutritional principles established within a conventional nutritional paradigm as well as providing standardised definitions of relevant terms. 

Regulatory Principles

Risk and Effectiveness

Consideration of the addition of vitamins or minerals to any food/nutrient combination will be made in the context of a risk assessment and, where appropriate, effectiveness assessment framework.  Risk assessment of vitamin or mineral addition applies to all categories of foods and purposes of addition, whereas, assessment of effectiveness applies only to mandatory fortification and addition to special purpose foods.  An assessment of the potential effectiveness of a food/nutrient combination is also a consideration in deciding whether voluntary fortification will be permitted however, the achievement of effectiveness cannot be assured.  Achievement of effectiveness would be assessed by measurement of an expected increase in the food or supply, or evidence of a decline in public health indicators of disease, and would depend on the selected food’s level of vitamin or mineral addition and the directions for intake or pattern of consumption by the target population group.

Risk Assessment Framework

Because the risk of excess vitamin or mineral consumption derives from the entire food and supplemental intake, and in many cases can be quantified through nutrient specific upper tolerable limits, standard methods can be applied to consideration of risk of total consumption from current and proposed sources.  Within the context of all regulatory principles, specific decisions about the addition of vitamins and/or minerals to foods, including setting an upper limit in any single food, are based on the risk to the population as a whole or to identified subgroups or excess vitamin or mineral intake.  Assessment of such intakes takes account of food and where information is available, supplement consumption, under existing and proposed conditions.

The risk to the population or identifiable subgroups of excess consumption of a vitamin or mineral is quantified by estimating the total consumption (worst case) of that vitamin or mineral from both natural and proposed added sources by undertaking a dietary intake assessment.  This estimate is compared with the Tolerable Upper Intake Level (UL) for that vitamin or mineral, as determined by the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences in the US[13]. 

The UL is the highest level of daily nutrient intake that is likely to pose no risks over time of adverse health effects to almost all individuals in the general population.  As intakes increase above the UL, the risk of adverse effects also increases.  ULs are derived from a risk-based approach that accounts for total intake of a nutrient from food, water and supplements if adverse effects have been associated with total intake.  However, if adverse effects have been associated with intake from supplements or food fortificants only, the UL is based on nutrient intake from those sources only, not total intake. 

Where a potential risk to the population or subgroups of exceeding the UL for a particular nutrient is identified, the fortification scenario models used in the dietary intake assessment are further refined to take into account uncertainties and limitations of the data.  For example, where voluntary permission is being considered, information on the market share of the proposed fortified product in Australia New Zealand or other countries are used as a guide for scenario models rather than assuming that there will be 100% uptake of the permissions by industry.  In other words, the models are refined and assessed in order to ascertain whether or not the potential risk is realistic.  If the potential for excess consumption still exists, the following risk management strategies could be applied:

                no permission for the nutrient addition granted;

                limited range of food or amount of the nutrient (e.g. limited to less than 25% RDI per reference quantity or ‘source’ claim only i.e. 10-<25% RDI per reference quantity); or

                permission granted for nutrient addition in conjunction with labelling advice about the risks.

Guiding Statement

To underscore the regulatory principles and to provide a clear rationale for the addition of vitamins and minerals to foods, a new high-level Guiding Statement has been developed which applies to the regulatory principles for general purpose foods and special purpose foods. 

The Statement embodies the concepts of assessment of risk and, where appropriate, of effectiveness that together form the framework within which the regulatory principles are applied.  Because the risk of excess vitamin or mineral consumption derives from the entire food and supplemental intake, and in many cases can be quantified through nutrient specific upper tolerable limits, standard methods can be applied to consideration of risk of total consumption from current and proposed sources. 

On the other hand, effectiveness is context specific and needs to be considered on a case-by-case basis in accordance with the purpose of the fortified food.  Achievement of effectiveness would be assessed by measurement of an expected increase in the food or food supply, or evidence of a decline in public health indicators of disease, and would depend on the selected food’s level of vitamin or mineral addition and the directions for intake or pattern of consumption by the target population group.

This Statement is based on that proposed by Health Canada[14] who contends that without such a Policy Recommendation:

                there is a risk that the addition of vitamins and minerals to foods would become disconnected from nutritional need, health benefit or purpose;

                food fortification could potentially seriously undermine the concept of total diet by encouraging consumers to rely on only a few, highly fortified foods rather than a well-balanced diet consisting of a variety of foods consumed in moderation; and

                the addition of vitamins and minerals to foods at levels that cannot be nutritionally justified would carry an implicit message to consumers that some benefit may accrue from consumption of micronutrients at those levels.

The development of a Guiding Statement clarifies for FSANZ, potential applicants, and all stakeholders that permission for the addition of vitamins and minerals to general purpose and special purpose foods cannot be sought on grounds other than according to the established regulatory principles.

The relevant regulatory principles in relation to general purpose foods are presented below.

Background

General purpose foods are those that are generally available for consumption by all members of the community.  Regulatory principles for the voluntary vitamin and mineral addition to general purpose foods were developed in 1995 and derived from the Codex General Principles.  These regulatory principles were last reviewed in 1999 as part of the development of joint Australia New Zealand food regulation, and are the following:

1.              Vitamins and minerals may be added, subject to no identified risks to public health and safety, at moderate levels (generally 10-25% Recommended Dietary Intake (RDI) per reference quantity) to some basic foods providing that the vitamin or mineral is present in the nutrient profile, prior to processing, for a marker food in the food group to which the basic food belongs.  The vitamin or mineral must be present at a level which would contribute at least 5% of the RDI in a reference quantity of the food[15].

1.              Specified foods may be fortified with vitamins and minerals to [potentially] address situations where there is reasonable evidence for a nutritional need in the population.

1.              Vitamins and minerals may be added, for the purpose of nutritional equivalence, to specified foods that substitute for certain basic foods.

1.              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 no identified risks to public health and safety, continue to be fortified with those vitamins and minerals at moderate levels.

1.              In general, claims to the effect that the particular food product is a ‘source’ or a ‘good source’ of a vitamin or mineral may be made providing a reference quantity of the food contains at least 10 percent or 25 percent of the RDI respectively for the particular vitamin or mineral and the food is a ‘claimable’[16] food.

In addition, Australia and New Zealand have mandated particular fortification measures in order to address one or more aspects of demonstrated serious public health need, although Australia has historically mandated and continued for the time being, more measures than New Zealand. 

Clarification and Elaboration

Several of the previously developed principles for voluntary addition are sufficiently elaborated to serve current regulatory requirements and need no further discussion.  These principles relate to modified restoration; nutritional equivalence; and the content claim criteria.  The historical precedent previously employed is now retained only as a footnote to the clarified regulatory principles for completeness.  Further clarification has been provided as to the conditions pertaining to voluntary and mandatory fortification however, this is not relevant for discussion here.  Neither is the clarification of the principles for mandatory fortification presented here

Voluntary fortification

Voluntary fortification is where food regulation permits industry to choose to add specified vitamins and/or minerals to particular foods to address certain public health concerns. 

Permission for such addition would be granted after an assessment of risk, not only of excess vitamin or mineral consumption but also of increased consumption of potentially inappropriate foods that would be promoted on the basis of their enhanced nutrient profile.  Depending on the extent of such risks, a maximum regulatory limit or maximum claim could be imposed, or the food not approved for fortification.

Where regulation permits voluntary addition, it is the food manufacturer who decides whether vitamins or minerals are to be added to his product; commercial considerations are a significant factor in such decisions.  From a public health perspective, permission for voluntary addition cannot be routinely relied upon to target improvements in public health even if the industry indicates its intention to fortify particular products.  This means that the community should be prepared to bear the opportunity cost to public health if industry chooses not to take up the regulatory permissions for voluntary fortification.

Where regulation permits it is

Eligibility of vitamin or mineral for voluntary fortification

Because of the uncertain impact of future permissions to voluntary fortify, it is appropriate that voluntary fortification be directed to lower intensity food-related public health concerns such as the proportion of the population or population subgroup whose customary nutrient intakes are inadequate.  This is similar to the Canadian approach but requires the following three elements to be determined:

                appropriate nutrient reference values;

                percentage of identified population subgroups whose intakes of vitamins or minerals are inadequate; and

                appropriate population subgroups for comparison of intakes and reference values.

Nutrient reference values

Several nutrient reference values can be used to assess nutrient intakes: most common for assessment of adequacy of intake are the Estimated Average Requirement (EAR), or Recommended Dietary Intake (RDI) or equivalent term.

An RDI is a nutrient intake estimate that allows for a safety margin, by accommodating variations in absorption and metabolism and applies to group rather than individual needs.  RDIs are designed to meet the needs of practically all healthy people.  An EAR is a value that represents the median requirement for the dietary intake of a particular nutrient in a given population group.  Values for EARs are often determined as part of the methodology for establishing recommended intakes for macronutrients, vitamins and minerals; both the United Kingdom and the United States/Canada establish EARs for this purpose[17],[18] 

At the time of this report, no EARs had been established for Australian or New Zealand populations, although several Australian RDIs[19] were previously developed by the addition of a safety margin to a predetermined average requirement.

An EAR can be used as a public health benchmark for comparing and evaluating nutrient intakes and is useful for this purpose because it is established directly from evidence of nutrient requirements and applies specifically to large populations. 

EARs established by other countries will be used to assess the adequacy of intakes, as Australia and New Zealand are yet to establish EAR values.  Only the United States and the United Kingdom have established EARs for their populations.  The United States Dietary Reference Intakes for vitamins and minerals are the most recent (1998-2001) and comprehensive, however the Dietary Reference Values produced by the United Kingdom are generally more compatible with Australian RDIs.  In a few cases the United States EAR is equivalent to, or greater than the Australian RDI!  Use of such values to assess population intakes at this time however could lead to greater emphasis being placed on these nutrients without confirmation that such an approach is appropriate for Australia and New Zealand.  Therefore United Kingdom EARs are preferred in the assessment of adequacy of nutrient intakes.  If such values do not exist, then United States values should be used as an alternative.

Percentage of the population with inadequate vitamin or mineral intakes

Figure 2 shows a diagrammatic representation of the way in which the distribution of intakes and requirements relate.  The area under the intake curve to the left of the EAR represents the proportion of the population whose intake is considered inadequate.

Figure 2:  Distribution of nutrient intake showing location of EAR when about 30% of the population’s intake is below the EAR

The adequacy of a nutrient intake can be assessed according to the percentage of the population whose intake is below the EAR.  Where the percentage is greater than 50%, the distribution of intakes has shifted to the left of the distribution of requirements because the EAR represents the median requirement for the population5.  Such a shift reflects the situation where there is an increased probability of individuals within the population group having an intake below their respective requirements for a nutrient, with greater percentages below the EAR reflecting a greater probability of inadequacy.  The converse of this trend is also true: smaller proportions of the population whose intake is below the EAR reflect situations where there is a reduced probability of inadequate intakes. 

The selection of a percentage of the relevant population group whose customary intakes are considered to be inadequate and therefore who may benefit from voluntary fortification, is arbitrary.  Clearly, the greater the proportion of the population whose intakes are below the EAR, the more conservative the decisions to permit voluntary fortification, but the greater potential impact of any permitted fortification.  On balance, FSANZ accepts that a case for voluntary fortification could be made if the percentage of the population or population subgroup whose customary vitamin or mineral intakes are below the EAR is at least 30%.

Population subgroups

An assessment of the adequacy of intakes of population subgroups as well as for the total population is important given the differences in food intake between the sexes and throughout the lifecycle.  The population subgroups used in the two sets of selected overseas nutrient reference values are themselves inconsistent and also inconsistent with those given for the Australian RDIs, which were used to describe the population groups in the Australian and New Zealand National Nutrition Surveys.  This inconsistency can be overcome in an assessment of dietary adequacy however, because FSANZ’s dietary exposure software program DIAMOND will shortly be able to aggregate the data for specified age/sex groups according to the EAR population subdivisions, and it is anticipated that second day adjustment factors will be able to be applied according to those subdivisions in the future.  It is not envisaged that adequacy of intake of smaller population groups would need to be assessed. 

Summary

The eligibility of particular vitamins or minerals to be permitted voluntary fortification in new foods would be considered in cases where the population group intake of that vitamin or mineral is assessed as inadequate.  The following points summarise the basis for that assessment.

1.              Adequacy of the vitamin and mineral intakes of the total population or population subgroups should be assessed by reference to the Estimated Average Requirement (EAR) established for that vitamin or mineral.

1.              The EARs established by the United Kingdom should be preferentially used.  If no such EAR value exists, then United States EAR values should be used as an alternative.

1.              A vitamin or mineral may be considered to be eligible for voluntary fortification in a new food if more than 30% of the whole population or more than one subgroup has a customary intake as shown by national nutrition surveys to be below the EAR 

1.              Population subgroups are defined as those given for the UK Dietary Reference Values.

Eligibility of food for voluntary fortification

The risk of nutritional inappropriateness of the food product to contain, and be promoted as containing, an added vitamin or mineral should be evaluated against the potential for that addition to decrease the percentage of the identified population whose intakes are assessed as inadequate.

Currently, the range of general purpose foods that are permitted to carry claims of natural vitamin or mineral content is restricted to those having a favourable nutritional profile and often less than 10% added sugars and fats.  The food industry has shown increasing interest in adding vitamins and minerals to a greater range of foods than currently permitted.  Many of these new foods would not be considered as core or basic foods and are often of relatively low nutrient density prior to fortification; they often contain significant proportions of added sugars, salt and/or fats.  Promotion of voluntarily fortified foods usually includes reference to the food’s increased vitamin or mineral content such as by a highlighted nutrient content claim on the front display panel accompanied by a Nutrition Information Panel (NIP) that quantifies the relevant vitamin or mineral content elsewhere on the package.  The promotion of such foods may confuse consumers as to the overall nutritional integrity or undesirability of the product if they are unable to interpret or unaware of the nutrition information also on the label. 

But are there any risks of expanding the range of foods eligible to contain added vitamins and minerals to include those of inherently lower nutritional value?  The findings of two such studies shed light on this issue.  In the results of a copy test of nutrient content claims and food health claims in advertising[20], the “Halo Effect Component” was described.  This research used word and pictorial advertisements to investigate the use by consumers of claims for foods that contain high levels of a beneficial nutrient such as fibre or calcium, but also contain high levels of a nutrient (such as sodium, saturated fat, or cholesterol) that, in sufficient quantity, can increase the risk of a diet-related disease.  Respondents on average underestimated the level of risk-increasing nutrients in these products when only quantitative written information (in the advertisement) about the risk-increasing nutrients were provided and required direct verbal information about these risk-increasing nutrients in order to correctly evaluate the healthfulness of the food product.

The results of another study[21] suggest that the presence of added value information (i.e. ‘new’ information such as a content claim or a low fat claim) is an important condition on whether or not a claim will have an impact.  Results of this study also show that the presence of a nutrient content claim is significantly associated with a greater probability of a search limited to the front panel, relative to a search that involves looking at the Nutrient Facts panel.  This would imply that consumers are less likely to look at the NIP (and therefore assess the quantities of other nutrients) of a product if it bears a nutrient content claim on the front.

The relative importance that consumers place on the presence of ‘new’ and positive information and a nutrient content claim on the front of a product suggest that it is important to establish criteria for selection of appropriate food vehicles for the addition of vitamins and minerals. Research suggests that consumers in general have difficulty weighing up positive information against the negative information.

Therefore specified foods may be voluntarily fortified with vitamins and minerals to potentially address situations where the food proposed for fortification is consistent with nationally endorsed guidance for healthy eating.  To avoid the promotion (by virtue of a nutrient content claim) of foods that might increase risk factors for certain diseases if consumed in excessive amounts or that have little nutritional value, compositional criteria should be applied to the selection of appropriate food vehicles for nutrient addition. 

The risk of potentially increased consumption of inappropriate foods

Foods that have been voluntarily fortified should be consistent with officially endorsed guidance for healthy eating such as the Dietary Guidelines.  There is potential for consumers to receive conflicting messages if foods such as confectionery and high fat and sugar desserts claim to be sources or good sources of added nutrients while the Dietary Guidelines recommend the consumption of these types of foods in small quantities or in moderation.

A further risk relates to the potential for inappropriate substitution of the fortified food for a natural source of the vitamin or mineral based on product similarity or perceived use.  This risk relates to a natural source of the vitamin or mineral being substituted for a fortified product which does not meet the Codex definition of a substitute food.  A substitute food is defined in the Codex General Principles as:

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.

The implications for inappropriate substitution include changes in nutrient intakes other than the vitamin or mineral proposed for addition.  If such a risk is identified, risk management strategies could be employed.  For example, if calcium-fortified orange juice displaces milk as a source of calcium, this may impact on the intake of other nutrients contained in milk that are not present in orange juice and orange juice does not meet the definition of a substitute food under the Codex General Principles.  At present, data for confirming such a risk is limited and market data is the best available for obtaining a longer term picture of consumer patterns.

There may be a need for new consumer education about how to use fortified foods as part of healthy eating.  In instances when voluntary permissions are granted, consumers may find it difficult to know whether they should select fortified foods or not.  Education programs would be important so that consumers did not lose sight of the value of the total diet.

Monitoring programs which would record the levels of uptake of the voluntary permissions granted would be useful to assess the potential effectiveness in assisting the population or identified sub-groups of the population to increase their intake of a particular nutrient.

Criteria for food selection

The proposed criteria for assessing the suitability of the food to be voluntarily fortified is based on a similar approach to that applied to ‘claimable foods’ as defined in Standard 1.3.2 – Vitamins and Minerals, and also that proposed for appropriate use of health claims.  Although these criteria are not strictly consistent with the composition of previously permitted foods, for the first time they provide sufficient detail to guide manufacturers and regulators on the voluntary addition of vitamins and minerals to foods.

The food category generally (in ready to consume form) must:

1.              have no more than 25% by ingoing weight of:

1.              added sugars[22]; and
2.              any ingredient comprising more than 75% triglyceride.

1.              contain no more than 800 mg sodium per manufacturer’s serve size.
2.              prior to vitamin and/or mineral addition, must also naturally contain at least one vitamin or mineral whose content is at least 5% of the Recommended Dietary Intake (RDI) as listed in the Schedule to Standard 1.1.1 per manufacturer’s serve size.

The limits on sugar and fat however are stated in terms of ingredients or added sugar- and fat-ingredients (recipe based) rather than on the total sugar or fat content (nutrient analysis) which might otherwise include naturally present sugars and fats.  A moderate nutrient density of the food is assured by the requirement that the food contain, per manufacturer’s serve, at least one vitamin or mineral at 5% of the RDI.  The sodium limit is generous in keeping with the currently permitted voluntarily fortified foods but it was still considered important to exclude some high salt foods.

The application of this Regulatory Principle should provide clear guidance on the appropriate foods for voluntary vitamin and mineral addition to assist industry in making application to amend the Code and to inform FSANZ’s internal decision-making processes. 

ATTACHMENT 5

FIRST REVIEW REPORT

APPLICATION A424

FORTIFICATION OF FOODS

WITH CALCIUM

1. Objectives of Review

The Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) has requested a First Review of a draft variation to Standard 1.3.2 – Vitamins and Minerals of the Australia New Zealand Food Standards Code (the Code).  Food Standards Australia New Zealand (FSANZ) is required to notify the Ministerial Council on the outcome of this Review by May 2005.

Application A424 – Fortification of Foods with Calcium seeks to amend Standard 1.3.2 – Vitamins and Minerals of the Code to permit the voluntary addition of calcium to fruit- and vegetable juices and drinks, soups and savoury biscuits. 

In May 2004, the Ministerial Council adopted a Policy Guideline on Fortification of Food with Vitamins and Minerals (Policy Guideline), which provides guidance on the addition of vitamins and minerals to food.  In accordance with the section 10 objectives of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), FSANZ in developing or reviewing food standards must have regard to Ministerial policy guidance.

Therefore, the objective of this Review is to reconsider the draft variations to Standard 1.3.2 taking into account the Ministerial Council’s concerns as outlined in Section 2, and the recently adopted Policy Guideline.

2.  Review on Grounds Requested by the Ministerial Council

The Ministerial Council has requested a First Review of Application A424 on the grounds that the draft Standard:

                is not consistent with the objectives of the legislation which establishes FSANZ;

                does not protect public health and safety;

                does not promote consistency between domestic and international food standards where these are at variance;

                does not provide adequate information to enable informed choice; and

                places an unreasonable cost burden on industry or consumers.

3.  Background

In December 2001, FSANZ received an Application from Food Liaison Pty Ltd on behalf of Arnott’s Biscuits Limited and Nutrinova Pty Ltd to amend Standard 1.3.2 – Vitamins and Minerals of the Code, to permit the voluntary addition of calcium to fruit- and vegetable juices, fruit- and vegetable drinks, fruit cordial, soups and savoury biscuits.  During the assessment process the Applicant notified FSANZ that fruit cordials were withdrawn from the requested list of foods.  Consequently the scope of Application A424 was narrowed to fruit- and vegetable- juices and drinks, soups and savoury biscuits. 

In September 2003, the FSANZ Board approved the Final Assessment of Application A424, including the draft variations to Standard 1.3.2 and notified the Ministerial Council.  This decision permitted the voluntary addition of calcium to the foods as requested by the Applicant.  As policy guidance on fortification was still pending, Application A424 was assessed against FSANZ’s Regulatory Principles for Vitamin and Mineral Addition to Foods (Regulatory Principles). 

In December 2003, the Ministerial Council sought a First Review of the draft variations to Standard 1.3.2 and agreed to allow FSANZ until May 2005 to complete the review in anticipation of the completed Policy Guideline.

In May 2004, the Ministerial Council adopted the new Policy Guideline that provides guidance on the addition of vitamins and minerals to food.  The Policy Guideline is divided into ‘High Order’ Policy Principles, which are based on FSANZ’s statutory objectives, and separate ‘Specific Order’ Policy Principles for both mandatory and voluntary fortification.  A copy of the Policy Guideline is at Attachment 1.  With the release of the Policy Guideline, the Regulatory Principles are now superseded.

4. Options

There are three options proposed for consideration under this review:

1.              re-affirm approval of the draft variations to Standard 1.3.2 of the Code as notified to the Ministerial Council; or

1.              re-affirm approval of the draft variations to Standard 1.3.2 of the Code subject to any amendments FSANZ considers necessary; or

1.              withdraw approval of the draft variations to Standard 1.3.2 of the Code as notified to the Ministerial Council.

5. Ministerial Council Review Grounds

The First Review of the draft variations to Standard 1.3.2 has been undertaken addressing the matters stated in the Ministerial Council’s request (as listed above) and also having regard to the new Policy Guideline.  Any issues relevant to the Policy Guideline that are not dealt with directly in the Ministerial Council’s grounds for review have been included in Section 5.6 of this report. 

5.1 Inconsistency with the objectives of the legislation which establishes FSANZ

FSANZ commenced work and completed its assessment of Application A424 prior to the adoption of the Policy Guideline.  Consequently this Review of the draft variations to Standard 1.3.2 will be undertaken in accordance with section 10 objectives of the FSANZ Act, which includes having regard to the new Policy Guideline. 

Accordingly this review will address the Policy Guideline’s ‘Specific Order’ Policy Principles for voluntary fortification as they relate to Application A424 and by so doing, will seek to address the ‘High Order’ Policy Principles, which reflect the FSANZ statutory objectives as set out in section 10 of the FSANZ Act.

5.2 Protection of public health and safety

5.2.1 Risk of calcium inadequacy/deficiency

The first ‘Specific Order’ Policy Principle for voluntary fortification requires that the permission to voluntarily add vitamins and minerals to food should only be permitted if one or more of five prerequisites is met (see Attachment 1).  The first ‘prerequisite’ states that the voluntary addition of vitamins and minerals to food can be permitted where there is a need for increasing the intake of a vitamin or mineral in one or more population groups demonstrated by actual clinical or sub-clinical evidence of deficiency or by data indicating low levels of intake.

FSANZ has assessed the adequacy of calcium intakes of the total population and population subgroups by reference to the United Kingdom estimated average requirement (EAR) for calcium[23] in the absence of Australian or New Zealand official EAR reference values. 

Nutritional inadequacy can be defined as more than 3% of the population having nutrient intakes below the EAR[24].  National data[25] indicates that 28.4% and 33.9% of the Australian and New Zealand populations respectively, do not meet the EAR for calcium.  Particular population groups with low calcium intakes include adolescent and adult females in Australia and New Zealand, New Zealand Maori, Australians of Asian ethnicity and non-dairy consumers in Australia and New Zealand. 

5.2.1.1 Conclusion

There is considerable evidence to indicate that there is an inadequate intake of calcium in the Australian and New Zealand populations, which meets one of the five prerequisites for permitting voluntary fortification in accordance with the first ‘Specific Order’ Policy Principle of the Policy Guideline.

5.2.2 Potential to address deficit

The second ‘Specific Order’ Policy Principle for voluntary fortification is that the permitted fortification has the potential to address the deficit or deliver the benefit to a population group that consumes the fortified food according to its reasonable intended use. 

The Final Assessment Report for Application A424 demonstrated that the addition of calcium to all proposed food categories has the potential to increase the calcium intake for the population or subgroups of the population whose intakes were assessed as inadequate.  Increasing the calcium intake of the population is consistent with national dietary guidance and has the potential to improve current inadequate calcium intakes.  The extent of the potential benefit, however, will depend on the uptake of this voluntary permission by industry.

The issue of bioavailability was also examined at Final Assessment and it was concluded that the addition of calcium to the proposed food categories has the potential to address the deficit.  It was noted that bioavailability is a complex issue and is affected by different factors, including long term nutrient intake imbalances, nutrient interactions at a single meal and individual variations in the ability to absorb and use various nutrients in the body.  It was also recognised that various calcium salts have different bioavailabilities in different foods. 

In relation to this matter, the Final Assessment Report concluded that recent research had shown that the particular forms of calcium salts suitable for addition to fruit- and vegetable-based beverages were as bioavailable as the calcium in milk, although the effect of calcium-fortified beverages on bone health appeared not to be as beneficial as that gained from milk consumption due to intrinsic factors in milk[26].

5.2.2.1 Conclusion

The potential exists to improve the calcium intake of population subgroups whose current intakes are assessed as inadequate and so meets the requirement of the second ‘Specific Order’ Policy Principle for voluntary fortification. 

5.2.3 Risk of excess calcium intake

The sixth ‘Specific Order’ Policy Principle states that permissions to fortify should ensure that the added vitamins and minerals are present in the food at levels which will not have the potential to result in detrimental excesses or imbalances of vitamins and minerals in the context of total intake across the general population.  The first part of this policy principle that relates to detrimental excesses will be discussed in this section (5.2.3) whereas the second part relating to dietary imbalances is discussed in Section 5.2.4.

At Final Assessment, FSANZ assessed the risk to the population of consuming excess calcium by estimating the total consumption of calcium from both natural and the proposed added sources and then comparing this to the Tolerable Upper Intake Level (UL) for calcium (2500 mg/day) [27]. The dietary intake assessment indicated that there is little risk of consumers exceeding the UL for calcium over a long period.

5.2.3.1 Conclusion

There is minimal risk to the population of consuming excessive amounts of calcium from a diet containing the calcium-fortified food requested in Application A424 and so this assessment meets, in part, the requirements of the sixth ‘Specific Order’ Policy Principle for voluntary fortification. 

5.2.4  Risk of dietary displacement

The remaining part of the sixth ‘Specific Order’ Policy Principle is that permissions to fortify should ensure that the added vitamins and minerals are present in the food at levels which will not have the potential to result in imbalances of vitamins and minerals in the context of total intake across the general population.

At Final Assessment, FSANZ concluded that the risk of dietary displacement from consuming calcium fortified soup and/or biscuits would be minimal.  The main risk identified by permitting calcium-fortified foods, as requested by Application A424, is that fruit- and vegetable- juices and drinks could displace milk in the diet.  This does not apply to those individuals who, for whatever reason, do not consume milk.