EXPLANATORY STATEMENT

PROPOSAL P295

Consideration of Mandatory Fortification with Folic Acid

Executive Summary

In May 2004, the Australia and New Zealand Food Regulation Ministerial Council (the Ministerial Council) asked Food Standards Australia New Zealand (FSANZ) to investigate mandatory fortification with folic acid as a possible means of reducing the incidence of neural tube defects (NTDs) which are serious birth defects.

FSANZ released an Initial Assessment Report in October 2004 and presented four options, namely: maintenance of the status quo; extension of permissions for voluntary folic acid fortification; mandatory folic acid fortification; and increased health promotion and education strategies to increase folate intakes.

FSANZ reduced the number of regulatory options considered at Draft Assessment to maintenance of the status quo and mandatory folic acid fortification.  FSANZ’s assessment seeks to determine how mandatory fortification can be implemented in Australia and New Zealand as Ministerial advice received in 2005 is that mandatory folic acid fortification is an effective strategy and requested that FSANZ expedite its process.

Internationally, a number of countries have reported successful mandatory folic acid fortification programs as an equitable and sustainable means of increasing the folic acid intake of women of child-bearing age (the target population) to reduce the incidence of NTDs. 

FSANZ drew on this international experience and selected bread-making flour (consumed as bread and bread products) as the food vehicle for mandatory folic acid fortification in Australia and New Zealand at Draft Assessment.  Following further targeted consultation and consideration of the international experience with folic acid fortification and Australian experience with thiamin fortification, FSANZ has refined the approach to specifically require mandatory fortification of bread as the final food consumed.  This approach provides a more predictable means of delivering folic acid intake to the target population whilst limiting intake in the non-target population and increases flexibility for industry in meeting the mandatory standard.

This Final Assessment Report therefore focuses on consideration of mandatory folic acid fortification of bread as a means of reducing the incidence of NTDs in Australia and New Zealand and includes:

• an assessment of the potential health benefits and risks of increased dietary intakes of folic acid by the Australian and New Zealand populations;

• technical issues regarding fortification of bread as the preferred food vehicle and level of folic acid concentration to achieve the desired health outcome;

• consideration of alternative approaches to mandatory fortification (as provided by several submitters) to achieve similar levels of effectiveness and safety;

• management of any identified health risks associated with the selected level of fortification;

• a revised cost-benefit analysis;

• associated communication and education strategies;

• monitoring and implementation issues; and

• presentation of a regulatory approach.

This report also addresses issues arising from public submissions and targeted stakeholder consultations. 

Reasons for the Decision

The reasons for this decision are:

• fortifying bread with folic acid, learns from and builds on international experience of mandatory fortification to reduce the incidence of NTDs;

• bread is an effective and technically feasible food vehicle for mandatory fortification;

• bread and bread products are staple foods consumed widely (more than 80%), consistently and regularly by the target population of women aged 16-44 years;

• fortification of bread will deliver a mean increase in folic acid intake in the target population of 101 µg and 140 µg in Australia and New Zealand respectively, resulting in an estimated reduction of between 14-49 out of 300-350 pregnancies in Australia and 4-14 out of 70-75 pregnancies in New Zealand affected by an NTD each year;

• on the available evidence, including overseas experience with mandatory fortification, the proposed level of fortification does not pose a risk to public health and safety.  The level has been set to minimise any potential health risks as a degree of uncertainty exists, particularly for the non-target population from increased folic acid intakes over the longer term;

• the cost-benefit analysis has indicated that mandatory fortification of bread with folic acid can deliver benefits that definitively exceed the costs:

-                 in Australia, when folic acid is added to bread making flour, the net-benefit from all NTDs avoided is $122 million each year ongoing.  In the case of live births the net-benefit is $21 million each year ongoing;

-                 in Australia, when folic acid is added at the later stages of bread production, the net-benefit from all NTDs avoided is $99 million each year ongoing.  In the case of live births there is a net-cost of $2 million each year ongoing;

-                 in New Zealand, when folic acid is added to bread making flour, the net-benefit from all NTDs avoided is $41 million each year ongoing.  In the case of live births the net-benefit is $4.3 million each year ongoing; and

-                 in New Zealand, when folic acid is added at the later stages of bread production, the net-benefit from all NTDs avoided is $39 million each year ongoing.  In the case of live births the net-benefit is $2.5 million each year ongoing.

• fortification of bread provides greater predictability in the level of folic acid consumed by the target and non-target groups and therefore greater confidence that the estimated reduction in NTDs will be achieved and that health risks to non-target groups will be minimised;

• fortification of bread provides flexibility for industry in determining the most appropriate and cost effective means of achieving mandatory fortification;

• the cost to consumers is likely to be less than 2% of the price of a loaf of bread;

• the fortification of bread does provide for some consumer choice through access to unleavened breads and unfortified flour; and

• it is consistent with Ministerial policy guidance on mandatory fortification.

Consultation

FSANZ received 148 submissions in response to the Draft Assessment Report for this Proposal during the public consultation period of 3 to 31 July 2006.  A full summary of submissions is at Attachment 2.

FSANZ also conducted intensive targeted consultation through a range of consultative mechanisms to discuss key issues and impacts of mandatory fortification with all stakeholder groups, namely the Australian and New Zealand baking and milling industries, supermarket in-store bakery representatives, organic industry representatives, government agencies, and consumer and public health organisations.

There was divergence of views regarding mandatory folic acid fortification both between and within stakeholder groups.  Most government submitters supported mandatory fortification on the condition that monitoring is in place prior to implementation.  Some public health and consumers groups supported mandatory fortification whereas others were opposed.  Industry was opposed to mandatory fortification.

Key issues raised included the effectiveness of mandatory fortification in reducing NTDs (based on the proposed fortification level) being not sufficient to justify population wide consumption of folic acid, possible health risks and future unknown health risks, lack of consumer choice, the impacts on industry, monitoring of mandatory fortification, enforcement and the importance of continuing other NTD risk reduction strategies. 

Key issues

Will mandatory fortification of bread with folic acid result in other health benefits? 

No other health benefits, apart from a reduced risk of NTDs, have been conclusively associated with an increase in folic acid intake.

Whilst a reduced risk of cardiovascular disease was previously reported as a potential health benefit, a review of current evidence (much of it published early in 2006) does not support this association.

Are there any possible health risks from mandatory fortification with folic acid?

The expected average increase in folic acid intake arising from mandatory folic fortification is unlikely to pose any increased risk of masking the diagnosis of vitamin B12 deficiency in older people or in the zinc status of the population.  The available evidence also suggests that folic acid is unlikely to interfere with anti-epileptic, antifolate or some anti-inflammatory drugs at folic acid intakes below one milligram per day.

A small proportion of young children (7% of 2-3 year olds in Australia) are expected to exceed the Upper Level of Intake (UL) for folic acid based on the proposed level of fortification.  Whilst this is undesirable, it is unlikely to pose a health risk as there is a considerable margin of safety inherent in setting the UL.  No comparable data on folic acid intakes among children under five years are available for New Zealand.

In addition to the potential health risks described above, there remains some uncertainty about other potential adverse health effects (e.g. cancer incidence and an increase in multiple births) from increased folic acid.  As a result of these uncertainties a risk management approach has been adopted consisting of:

• the requirement to ensure the level of folic acid in the final food meets a specified range, rather than placing the requirement on the folic acid content of the flour;

• a conservative approach to the level of fortification;

• the inclusion of an upper limit in the standard; and

• identifying the need to monitor potential health risks.

These elements together limit the intake in non-target populations, provide greater predictability regarding folic acid consumption and establish a mechanism to inform a review of the standard which is proposed within five years of implementation.

Does mandatory fortification allow for consumer choice?

Under mandatory fortification nearly all breads will be fortified.  This will include bread and bread rolls, sweet buns, fruit bread, English style muffins, some flat breads and bread crumbs. Breads which fall outside the definition of ‘bread’ in the Australia New Zealand Food Standards Code[2], will not be required to be fortified with folic acid. 

Some unfortified products such as unleavened flat breads, hot plate products such as crumpets and pikelets, pizza bases, and retail flours will provide consumers with other options.

Consumers will be informed about the addition of folic acid to bread through labelling that requires all ingredients of a product to be identified in the ingredient list. 

How will industry implement mandatory folic acid fortification?

Mandatory fortification will require all bread to contain folic acid within a prescribed range of 80-180 micrograms (µg) of folic acid per 100 g of bread.  Bread manufacturers will need to decide the most suitable and cost effective methods of fortifying for their particular bread production process.  Folic acid could be added through the use of flour fortified with folic acid, dry ingredients such as a bread improver[3] fortified with folic acid, a complete bread premix which has been fortified with folic acid, or a folic acid vitamin premix which is added to the dough.

FSANZ will prepare an implementation guide, education materials, and, if required, workshops to assist industry.  Industry will have 15 months from when the new standard is gazetted to comply with the mandatory fortification requirements.

How will mandatory fortification be monitored?

Responsibility for establishing and funding a monitoring system extends beyond FSANZ’s responsibility under the Food Standards Australia New Zealand Act 1991.  FSANZ will, however, routinely monitor some elements of the system such as:

• tracking changes in voluntarily fortified foods;

• updating the folic acid composition of foods in the food composition databases;

• tracking labelling changes on fortified foods;

• tracking changes in food consumption patterns for different demographic groups in key food categories that are likely to be fortified; and

• researching consumers’ attitudes and behaviour towards fortified foods.

Monitoring other elements of the impact of mandatory folic acid fortification, particularly the main outcome measure of a change in the national rate of NTDs, will require involvement of health and regulatory agencies at a Commonwealth, State and Territory level in Australia and the New Zealand Government.  Other outcome measures, such as cancer incidence, are already routinely collected and reported and will contribute to baseline data for the monitoring system.

Further information about the elements of and responsibilities for establishing a monitoring system are provided in Section 18 of this report and at Attachment 12.

What other strategies are planned to support mandatory fortification?

FSANZ recognises that mandatory fortification is one strategy in NTD prevention, and that other strategies will continue to be important including the existing voluntary fortification of other foods, the promotion of supplement use and education for women of child-bearing age.

FSANZ will talk with relevant industry members and government agencies to ensure that recommendations about supplement use take account of expected increases in dietary folic acid intake among women of child-bearing age.

FSANZ has prepared a communication and education strategy for mandatory folic acid fortification that aims to increase awareness among all target audiences of the proposed standard for mandatory folic acid fortification and its implementation.  To implement the strategy, FSANZ will seek opportunities to collaborate with organisations to provide information and education about the proposed standard to consumers, industry, health professionals and other key stakeholders.

FSANZ has begun to collaborate with a range of organisations as optimal reduction in the incidence of NTDs depends on these strategies being collaborative and sustained.

Implementation

Following completion of the Final Assessment for this Proposal, the FSANZ Board will notify the Ministerial Council of the decision.  Subject to any request from the Ministerial Council for a review, the proposed draft variations to the Code (Attachment 1) will come into effect 15 months from gazettal.

To assist industry, enforcement agencies and other stakeholders with the implementation of this mandatory fortification standard, FSANZ will develop an Implementation Guide.

CONTENTS

Executive Summary

Consultation

Key issues

Will mandatory fortification of bread with folic acid result in other health benefits?

Are there any possible health risks from mandatory fortification with folic acid?

Does mandatory fortification allow for consumer choice?

How will industry implement mandatory folic acid fortification?

How will mandatory fortification be monitored?

What other strategies are planned to support mandatory fortification?

Implementation

Introduction

Scope of this Proposal

1. Background

1.1 Folate terminology and forms

1.2 Nutritional role of folate

1.3 Neural Tube Defects (NTDs)

1.4 Regulation of folic acid in foods in Australia and New Zealand.

1.5 Existing mandatory fortification requirements

1.6 International regulation of folic acid in foods

Sources:

2. Current approaches to increasing folate intake

2.1 Folic acid supplement recommendations and availability

2.2 Folic acid supplement use among women of child-bearing age

2.3 Promotion of folate-rich foods and folic acid supplements

2.4 Voluntary fortification of foods with folic acid

2.5 Summary of the current approach to increasing folate intake

3. The Health Issue

4. Objectives

RISK ASSESSMENT of mandatory fortification

5. What are the potential health benefits, particularly regarding rates of NTDs, and potential health risks from increases in folic acid intake?

5.1 Neural tube defects

5.2 Masking of the diagnosis of vitamin B12 deficiency

5.3 Cardiovascular disease

5.4 Cancer

5.5 Cognitive function

5.6 Unmetabolised circulating folic acid

5.7 Other effects during pregnancy

5.8 Other potential health risks

6. What is an appropriate food vehicle and what level of folic acid intake can be achieved among women of child-bearing age using mandatory fortification?

6.1 Selection of food vehicle

6.2 Dietary targets

6.3 Fortification scenarios

6.4 Assessment of baseline folic acid intakes

6.5 Selection of folic acid concentrations

6.7 Dietary intake assessment for women of child-bearing age

6.8 Robustness of the estimates used to determine bread consumption and folic acid intakes

6.9 Alternative approaches to mandatory fortification

7. Based on the expected increase in folic acid intake from mandatory fortification what are the likely health benefits and risks?

7.1 Expected reduction in neural tube defects

7.2 Health risks to the whole population

8. Risk assessment summary

risk management of mandatory fortification

9. Identification of risk management issues

9.1 Technical and industry issues for mandatory fortification

9.2 Consistency with Ministerial Policy Guidance

9.3 Consumer issues

9.4 Factors affecting safe and optimal intake

9.5 Summary

10. Regulatory options

10.1 Option 1 – Current approach – the status quo

10.2 Option 2 – Mandatory folic acid fortification of bread products

11. Impact Analysis

11.1 Affected parties

11.2 Cost-benefit analysis of regulatory options

12. Comparison of Options

13. Strategies to manage risks associated with mandatory fortification

13.1 Managing safety and effectiveness

13.2 Consumer Choice

13.3 Labelling and information provision

Communication and consultation

14. Communication and Education Strategy

15. Consultation

15.1 Initial Assessment

15.2 Draft Assessment

15.3 Targeted consultation process

15.4 Outcomes from targeted consultations

15.5 World Trade Organization

CONCLUSION

16. Conclusion and the decision

17. Implementation and Review

17.1 Transitional Period

17.2 Regulatory compliance issues

17.3 Communication and education strategy for the preferred regulatory option

18. Monitoring

18.1 Monitoring and review of the impact of mandatory folic acid fortification

18.2 Comments on monitoring in submissions

References

Attachment 1 - Draft variation to the Australia New Zealand Food Standards Code

Attachment 2 - FIRST REVIEW REPORT

Attachment 3 - Draft variations to the Australia New Zealand Food Standards Code (Post-Ministerial Council Consideration)

separate Attachments (Final Assessment Report):

The following attachments are available on the FSANZ website at http://www.foodstandards.gov.au/standardsdevelopment/proposals/proposalp295considerationofmandatoryfortificationwithfolicacid/index.cfm

Attachment 2 – Summary of Submissions from the Draft Assessment Report

Attachment 3 – Policy Guideline

Attachment 4 – Impact of mandatory fortification in the United States of America

Attachment 5 –  Current approach to increasing folate intake among women of child-bearing age

Attachment 6 –  Potential health benefits and risks of increased folic acid intake

Attachment 7a  – Methodology and Results of Dietary Modelling at final assessment

Attachment 7b  – Methodology and Results of Dietary Modelling at draft assessment

Attachment 8  – Evaluation of health risk from mandatory folic acid fortification

Attachment 9  – Wald Model:  NTD Risk according to increments of folic acid intake

Attachment 10 – Food Technology Report

Attachment 11a – fortification of bread with folic acid

attachment 11b – Cost benefit analysis of fortifying the food supply with folic acid

Attachment 12 – development of a bi-national monitoring system to track the impact of regulatory decisions on mandatory and voluntary fortification

separate Attachments (First Review Report – Attachment 2):

The following attachments are available on the FSANZ website at http://www.foodstandards.gov.au/standardsdevelopment/proposals/proposalp295considerationofmandatoryfortificationwithfolicacid/index.cfm

Attachment 2 – Informing a Strategy for Increasing Folate Levels to Prevent Neural Tube Defects: A Cost-effectiveness Analysis of Options; L Segal, K Dalziel and R Katz, April 2007

Attachment 3 – Mandatory Folic Acid Fortification of Bread-making Flour in Australia; Gerard McMullen, March 2007

Attachment 4 – Ministerial Council’s Policy Guideline on Fortification of Food with Vitamins and Minerals

Attachment 5 – Additional information on the effectiveness and potential health benefits and risks of increasing folic acid intakes in the population 

Attachment 6 – Impact of Mandatory Fortification in the United States of America

Attachment 7 – Dietary intake assessment report

Attachment 8 – Communication and Education Strategy

Introduction

Neural tube defects (NTDs) are a group of birth defects, which occur in utero during the development of the brain or spinal cord.  Since the early 1990s there has been convincing evidence that increased intakes of folic acid can reduce the risk of NTDs.  As a result, a number of countries including Australia and New Zealand have adopted policies to increase the folate intake of women prior to and during pregnancy. 

The primary prevention strategies in Australia and New Zealand have been, either singly or in combination: promotion of diets high in naturally occurring folate; promotion of folic acid supplements during the peri-conceptional period; and voluntary fortification of the food supply with folic acid.

Mandatory fortification has been under active consideration since May 2004 when the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) adopted a Policy Guideline on the Fortification of Food with Vitamins and Minerals (see Attachment 3).  At that time, Ministers also requested that Food Standards Australia New Zealand (FSANZ) give priority consideration to mandatory fortification with folic acid.  FSANZ raised this Proposal (Proposal P295) and released an Initial Assessment Report for public consultation in October 2004.

In December 2004, FSANZ sought advice from the Food Regulation Standing Committee (FRSC) on two policy issues:

• whether mandatory fortification with folic acid is the most effective public health strategy; and

• a process to establish a health monitoring and review system in support of mandatory fortification.

FRSC undertook a process to clarify these policy issues which included seeking advice from the Australian Health Ministers’ Advisory Council (AHMAC) and the Australian Health Ministers’ Conference (AHMC).  An Expert Panel convened by AHMAC[4] reported that mandatory fortification fulfilled their criteria[5] of effectiveness, equity, efficiency, certainty, feasibility and sustainability required for an effective public health strategy and advised Health Ministers to support mandatory fortification as ‘the most effective public health strategy for increasing folate intakes’.

In October 2005, the Ministerial Council noted the advice of AHMAC and AHMC that mandatory fortification with folic acid is an effective public health strategy subject to clinical safety and cost-effectiveness.  FSANZ was asked to progress consideration of mandatory fortification with folic acid as a matter of priority and on this basis expedited the consideration.

In July 2006, FSANZ released a Draft Assessment Report proposing mandatory folic acid fortification of bread-making flour (consumed as bread and bread products) as the preferred regulatory approach.  FSANZ received 148 submissions with the majority of public health and government agencies in favour of mandatory fortification and with some public health and consumer groups and industry opposed.

This Final Assessment Report seeks to refine, following public consultation and other targeted consultation activities, the preferred regulatory option as proposed at Draft Assessment to reduce the incidence of NTDs in Australia and New Zealand.  The Report provides a description of the current approach as well as an assessment of the health benefits and risks of mandatory fortification, refinement of the preferred food vehicle, management of any identified risks, a revised cost-benefit analysis, associated communication, education, monitoring and implementation issues and recommends a regulatory approach.  Issues arising from public submissions and targeted stakeholder consultation have also been addressed where possible in this Report.

Work on developing a monitoring scheme for mandatory folic acid fortification is currently underway by a FRSC working group.  FSANZ has adapted the draft framework prepared by the FRSC working group and outlined the potential elements of a monitoring system that aims to assess the impact of mandatory fortification of the food supply with folic acid on consumers (see Attachment 12).  Responsibility for establishing and funding a monitoring system to assess the impact of a mandatory fortification on the population extends beyond FSANZ’s responsibilities under the FSANZ Act 1991, and will require the concomitant involvement of health and regulatory agencies at a Commonwealth, State and Territory level in Australia and the New Zealand Government.

Refer to the Glossary and Abbreviations and Acronyms for a list of definitions and abbreviations used in this Report.

Scope of this Proposal

At Initial Assessment four options were presented, namely: maintenance of the status quo; extension of permissions for voluntary folic acid fortification; mandatory folic acid fortification; and increased health promotion and education strategies to increase folate intakes.

On the basis of the Ministerial advice that mandatory fortification with folic acid is an effective strategy, FSANZ reduced the number of regulatory options considered to two at Draft Assessment and for this Final Assessment.  These are maintenance of status quo (including existing voluntary folic acid fortification) and mandatory fortification. 

The scope of this Proposal reflects the relative success of international experience with mandatory folic acid fortification programs and the experience to date of this being able to deliver an equitable, sustained and predictable response to further reducing the incidence of NTDs in Australia and New Zealand.

1. Background

1.1 Folate terminology and forms

The following terms are used frequently throughout the report.  For further details about definitions refer to the Glossary.

Folate is a water-soluble B-group vitamin.  The term folate is used generically to refer to the various forms of the vitamin, both naturally-occurring and synthetic, and its active derivatives (Department of Health, 2000).

Naturally-occurring folate is the form of folate found in a wide variety of foods including green leafy vegetables, cereals, fruits, grains, legumes, yeast extract, and liver.  The term naturally-occurring folate is used in this document, to differentiate it from folic acid added to food in fortification.

Folic acid, or pteroylmono-glutamic acid (PGA), is the most common synthetic form of folate and is the form used in fortification and in the majority of supplements.  Folic acid is rarely found occurring naturally in foods (NHMRC, 1995).

Dietary folate refers to folate that is consumed in the diet, both naturally occurring and folic acid added through fortification.  This term does not include folate consumed through supplements.

5-methyl tetrahydrofolate (5-methyl-THF) is the principal form of folate that circulates in the blood.  5-methyl-THF can be synthesised and added to food as a fortificant, however, this form of folate is less stable in the final product than synthetic folic acid.

Serum folate refers to the level of 5-methyl-THF that is present in the blood.

Unmetabolised free folic acid is folic acid that has not been converted to methyl-THF following digestion, and therefore circulates in the blood as a free form of folic acid.

1.2 Nutritional role of folate

Folate is used by the body in two important pathways: the DNA cycle and the methylation cycle.  Folate is essential for DNA synthesis as without it living cells cannot divide.  The need for folate is higher when cell turnover is increased, such as in foetal development.  The methylation cycle provides the cell with an adequate supply of S-adenosylmethionine, which acts a methyl donor in a wide range of methylation reactions.  Homocysteine is methylated by 5-methyl-THF to produce the amino acid methionine.

Recommended levels of intake of essential nutrients, including folic acid, have been established to:

• avoid deficiency in the majority of a healthy population;
• minimise health risks from excess nutrient consumption by setting an upper level of intake, where appropriate; and
• optimise nutrient intake for lowering chronic disease risk.

To capture the different levels, a range of values is given for each nutrient.  For folate these include: an estimated average requirement (EAR[6]), a recommended dietary intake (RDI[7]) and an upper level of intake (UL[8]) for each age and gender group.  These levels of intake are termed nutrient reference values (NRVs) and have been recently revised by the NHMRC[9]. 

The NRVs recommend increased levels of folate intake to those previously published in 1991.  The increased folate recommendations are based on new data which looked at the association between folate intake and homocysteine levels in the blood.  The new EAR and RDI for folate are expressed as ‘dietary folate equivalents’ or DFEs[10], which reflect the considerable difference in bioavailability (see Section 6.1.4) between naturally-occurring folate and folic acid.  The new folate RDI for men and women is 400 µg as DFEs which replaces the previous folate RDI of 200 µg per day.

‘Women capable of, or planning, pregnancies should consume additional folic acid as a supplement or in the form of fortified foods at a level of 400 µg/day folic acid for at least one month before and three months after conception, in addition to consuming food folate from a varied diet’ (NHMRC and NZMoH, 2006).

The adult UL for folate (1,000 µg per day of folic acid) has been set based on the potential for regular intakes above this level, by the elderly in particular, to mask the diagnosis of vitamin B12 deficiency (see Section 5.2.1).  The UL set for adults has been applied to younger age groups on a relative body weight basis.  However, vitamin B12 deficiency is rare in children, and so the relevance of this endpoint and hence the risk to children is not clear.

Individual folate requirements can be affected by factors such as smoking, certain drugs and genetic variations.  Inadequate folate intake leads to sub-optimal folate status.  Limited data exist on the folate status of the Australian and New Zealand populations (see Section 2.4.2) although those ‘at risk’ of deficiency may be as high as one in three in some Australian population sub-groups (Abraham and Webb, 2001). 

Foods naturally high in folate are green leafy vegetables (such as broccoli and spinach), nuts, orange juice, some fruits and dried beans and peas.  Cereals are moderate sources of folate.  Based on the national nutrition surveys conducted in Australia and New Zealand in 1995 and 1997 respectively, cereals and cereal-based dishes, vegetables and legumes contributed nearly 60% of naturally-occurring folate in the adult diet (NZMoH, 1999; ABS, 1999).  These surveys were conducted prior to or about the time of the introduction of voluntary fortification.

1.3 Neural Tube Defects (NTDs)

NTDs are a group of birth defects, which arise during the development of the brain and spinal cord in utero.  In the very early stage of pregnancy, a band of cells along the dorsal surface of the embryo develop into a hollow tube called the neural tube, which eventually forms the spinal column and central nervous system.  This process, called neurulation, is completed by day 22 to 28 after ovulation (Van der Put et al., 2001a; Verity et al., 2003).  Incomplete closure of the neural tube may lead to one of the following three neural tube defects:

• Spina bifida – This is a condition whereby incomplete closure of the neural tube results in the spinal cord being exposed or protruding through a gap in the spine.  This may result in the spinal nerves not being fully developed.  The proportion of infants with spina bifida who survive beyond one year of age in both Australia and New Zealand is likely to be in the range of 70-90%. 

• Anencephaly – This condition is characterised by a failure of the anterior neural tube to close, resulting in the total or partial absence of the cranial vault and brain tissue.  Infants are usually stillborn or die shortly after birth.  Together spina bifida and anencephaly account for 90% of all cases of NTDs. 

• Encephalocoele – This condition is characterised by the meninges and/or brain tissue extruding through a defect in the skull.  This is the least frequent of the neural tube defects.  The survival pattern of encephalocoele results in a low proportion of stillbirths, the majority of deaths occurring within the first year of life, although long-term survival after that is similar to children born with spina bifida.

The process of brain and spinal cord development can be disrupted by genetic and environmental factors.  The risk of NTDs is increased by: certain single-gene disorders and chromosomal anomalies; maternal factors such as diabetes mellitus; use of anticonvulsant medication; and inadequate folate intake.  The risk is also increased in women who have previously had a NTD-affected pregnancy.  Differences in the distribution of NTD cases have also been associated with geographical location, ethnicity, seasonal variation, maternal age, and socioeconomic status (Van der Put et al., 2001b).

In Australia, 300-350 pregnancies are affected each year by a neural tube defect.  In New Zealand there are approximately 70-75 cases per year (see Attachments 5 and 9). 

The following terms in relation to NTDs are used frequently throughout the report.  For further details about definitions refer to the Glossary (page 73).

Incidence: The number of live births, stillbirths and terminations affected by an NTD expressed as a rate per 1,000 total births[11].  As data on the number of terminations affected by an NTD is frequently incomplete, some authors use the term ‘prevalence’.

Birth prevalence: The number of live births and stillbirths affected by an NTD expressed as a rate per 1,000 total births.

The terms ‘incidence’ and prevalence’ usually refer to a reference time period e.g. per year.  In this report, however, these terms often refer to periods much longer than a single year and in some cases the reference time period is not specified.

1.4 Regulation of folic acid in foods in Australia and New Zealand.

Since 1995, in Australia, and 1996 in New Zealand, folic acid has been permitted to be voluntarily added to the following foods: flour; savoury biscuits; breads; breakfast cereals; vegetable and meat extracts; pasta; fruit and vegetable juices and drinks; and beverages derived from legumes.  Folic acid may also be added to legume analogues of dairy foods and meat but in smaller amounts.  More recently voluntary folic acid fortification permissions have been extended to cereal based beverages e.g. rice and oat ‘milks’.  These permissions are provided in Standard 1.3.2 – Vitamins and Minerals of the Australia New Zealand Food Standards Code (the Code).

Under the existing food regulations, permitted claims made on the presence of a vitamin and mineral in a food refer to the total of both naturally-occurring and added forms of the nutrient.  In the case of dietary folate in food the amount declared on a label is the sum of naturally-occurring folate and added folic acid and is listed as ‘folate’ in the Nutrition Information Panel.  The changes to the NRVs for folate will require amendments to relevant standards in the Code, which may in the future impact on composition and nutrition labelling requirements.  These amendments will occur in a separate review process.

Under Standard 1.1A.2 – Transitional Standard – Health Claims, a health claim highlighting the link between increased maternal dietary folate intake and reduction in NTD risk is permitted for some fortified and non-fortified foods that contain at least 40 g folate per serving.  The claim should state that increased maternal folate consumption in at least the month before and three months following conception may reduce the risk of NTDs.  It must also include the recommendation that women consume a minimum of 400 g of folate per day during this time.

FSANZ is currently working on Proposal P293 – Nutrition, Health and Related Claims, to develop a new standard for nutrition and health claims.  The new standard (draft Standard 1.2.7 – Nutrition, Health and Related Claims) will permit a wider range of claims in the future including a proposed revised folate-NTD health claim.  The temporary provision for the current folate-NTD claim has been in place since 1998, and will cease to have effect two years from the commencement of the new health claim standard.

1.5 Existing mandatory fortification requirements

Mandatory fortification of food with thiamin and vitamin D has existed in Australia for over 15 years; however, there is currently no mandatory fortification of food in New Zealand.  Standard 2.1.1 – Cereals and Cereal Products of the Code requires flour for making bread to be fortified with thiamin in Australia only.  Mandatory fortification of table edible oil spreads and table margarine with vitamin D in Australia is regulated under Standard 2.4.2 – Edible Oil Spreads of the Code. 

1.6 International regulation of folic acid in foods

1.6.1 Codex Alimentarius

The Codex Alimentarius does not mandate the addition of particular nutrients to certain foods other than some special purpose foods.  For generally consumed foods, the General Principles for the Addition of Essential Nutrients to Foods[12] state that essential nutrients may be added to foods for the purposes of restoration, nutritional equivalence of substitute foods, fortification[13], or ensuring the appropriate nutrient composition of a special purpose food. 

1.6.2 Countries with mandatory folic acid fortification

A number of countries have introduced mandatory requirements for folic acid fortification of foods in an effort to reduce the incidence of NTDs.  These include Canada, the United States, Indonesia, and a number of African and South American countries including Chile.  In these countries, the most common food fortified with folic acid is wheat flour.  A number of other countries are currently considering mandating folic acid fortification of flour, and include the United Kingdom and Ireland.  The Food Safety Authority of Ireland has recently recommended mandatory folic acid fortification of all bread, with a few minor exceptions to provide for some consumer choice[14]. 

Canada and the United States, countries with similar food supplies as Australia and New Zealand, have both mandated folic acid fortification of flour and other grain products (Table 1).  

Table 1:   Folic acid fortification in Canada and the United States

Sources:

1. Canadian Government ( 1998)

2. USFDA ( 1996g)

In the United States, these food vehicles were chosen because they are staple food products for most of the population (including 90% of the target group) and have a long history of being successful vehicles for fortification (USFDA 1996e; USFDA 1996f, see Attachment 4).  In addition, a cost-benefit analysis undertaken following the introduction of mandatory fortification in the United States found a considerable net benefit associated with the fall in NTDs (Grosse et al., 2005, see Attachment 11).

2. Current approaches to increasing folate intake

The primary prevention strategies employed in Australia and New Zealand since the early 1990s to reduce the risk of inadequate folate intake during the peri-conceptional period, and the attendant risk of NTDs, have been:

• promotion of folic acid supplements and diets containing foods naturally rich in folate;
• voluntary fortification of the food supply with folic acid and subsequent promotion of fortified foods; and
• a folate-NTD health claim.

These strategies are summarised below.  Further detail about the current strategies to increase folate and/or folic acid intake, improve folate status and reduce the incidence of NTDs is described in Attachment 5.

2.1 Folic acid supplement recommendations and availability

Folic acid supplementation during the peri-conceptional period can reduce the likelihood of a pregnancy affected by an NTD (Bower and Stanley, 1989; MRC Vitamin Study, 1991; Czeizel and Dudas, 1992; Berry et al., 1999; Lumley et al., 2001). 

Australia and New Zealand introduced health policies recommending women take folic acid supplements during the peri-conceptional period in the early 1990s.  

2.1.1 Australia

In Australia, the current NHMRC recommendation is that women capable of, or planning a pregnancy, should consume additional folic acid as a supplement or in the form of fortified foods at a level of 400 µg per day for at least one month before and three months after conception, in addition to consuming naturally-occurring folate in foods (NHMRC and NZMoH, 2006).

Folic acid supplements and multivitamin supplements containing folic acid can be purchased at pharmacies, health foods stores and supermarkets.  Folic acid supplements generally contain 500 µg, with 5,000 µg (or 5 mg) folic acid daily dose supplements available for women at high risk of an NTD-affected pregnancy.  Multivitamins marketed to peri-conceptional, pregnant and breast-feeding women contain folic acid levels ranging from 200 µg to 800 µg. 

2.1.2 New Zealand

In New Zealand, the Ministry of Health recommends that all women planning a pregnancy, or who are in the early stages of pregnancy, take an 800 µg[16] folic acid tablet daily for at least four weeks before, and 12 weeks after conception to reduce the risk of NTDs.  

Women at high risk of a pregnancy affected by an NTD are recommended to take a daily 5,000 µg (or 5 mg) folic acid tablet for the same period of time (NZMoH, 2006).

Eight hundred microgram folic acid supplements are registered medicines, and can be purchased over the counter in pharmacies.  Dietary supplements (such as multivitamins) containing folic acid doses ranging from 30-350 µg can be bought from supermarkets, pharmacies and health food shops (NZMoH, 1999).  Dietary supplement regulations[17] limit folic acid in non-prescription folic acid tablets and multi-vitamin tablets to no more than 300 µg per tablet.  New Zealand health authorities do not recommend non-medicine folic acid tablets for NTD prevention because the amount of folic acid does not meet the 400 µg recommended for NTD risk reduction.

2.1.3 Online sales

Online sales of pharmaceuticals are an emerging trend.  Folic acid supplements with varying quantities of folic acid (up to 5,000 µg (or 5 mg) tablets) are available for purchase online.

2.2 Folic acid supplement use among women of child-bearing age

To maximise effectiveness, sufficiently high dose folic acid supplements must be taken consistently during the peri-conceptional period.  The proportion of women of child-bearing age regularly taking folic acid during the recommended period is not high.  Recent data from a study in Western Australia indicated that 28.5% of women who had had a live born baby without birth defects between 1997 and 2000 had taken 200 µg or more of folic acid from supplements daily in the peri-conceptional period (Bower et al., 2005).  Better educated women and/or those 25 years or older were more likely to take this supplemental level of folic acid.  This result is despite a sustained campaign in Western Australia promoting the use of folic acid supplements to women of child-bearing age.

Data collected in South Australia suggests evidence of an increase in folic acid supplement use before and in the first three months of pregnancy among women who had given birth in the last three years; although the dose is unknown (Haan pers. comm.).  Watson et al. (2006a) report that 46% of recent mothers in NSW, but only 36% in Victoria, took folic acid appropriately and an additional 12% and 38%, respectively took some folic acid supplements, although the frequency and dosage is not reported and so it is not known whether this was sufficient to achieve the full benefit.  An additional number of women either increased their intakes of naturally-occurring folate or did not alter their intake because they thought it was already adequate.  In total, 80% and 82% of NSW and Victorian women who had recently given birth had taken some action to assess their folate intakes.  It is not known how many took an inappropriate action.

In New Zealand, results from two different studies found that the proportion of women who reported taking folic acid supplements during the peri-conceptional period (although not necessarily daily) ranged from 11-17% (Schader and Corwin, 1999; Ferguson et al., 2000).  There are no data on supplement dosage taken in New Zealand.  The lower percentage reporting taking supplements in New Zealand may be due to the fact that the New Zealand studies surveyed all women whereas the Australian studies surveyed women who had recently had a baby.

There are several impediments to the effectiveness of folic acid supplements as a strategy to reduce the incidence of NTDs including a high proportion (about 50%) of unplanned pregnancies; lack of knowledge and awareness among all women of child-bearing age of the appropriate action; knowledge about the dose and when to take folic acid supplements; and their cost and availability.

2.3 Promotion of folate-rich foods and folic acid supplements

Three national campaigns have been implemented in Australia, together with a number of State-based campaigns to promote increased consumption of folate-rich foods and folic acid supplementation.  There have not been any publicly funded campaigns in New Zealand.

Evidence that the risk of NTDs can be reduced by increased consumption of naturally occurring folate alone is lacking (Green, 2005[18]).  Thus, recommendations to reduce the risk of NTDs focus on 400 µg of synthetic folic acid per day either in supplements or from fortified foods, in addition to the naturally-occurring folate in foods.

2.4 Voluntary fortification of foods with folic acid

In 1994, the NHMRC estimated that NTDs could be reduced by up to two-thirds if women increased their folate intake.  It concluded that there was sufficient evidence to recommend mandatory fortification of flour and voluntary fortification of a number of other foods including breakfast cereals, cereal flours, yeast extracts and fruit and vegetable juices (NHMRC, 1995).  As a practical first step, voluntary fortification was recommended and in 1995, voluntary folic acid permissions for a range of foods were included in the Code.

In 1998, approval for a folate-NTD health claim pilot was granted for certain foods.  In recent years there has been limited uptake of the folate-NTD health claim with the exception of breakfast cereals.  Currently there are very few products using the health claim.  The reasons for this are unclear, but may include the lack of broad appeal of the folate-NTD health claim which has been expressed by industry (ANZFA, 2000).  The increased availability of folate-fortified foods has occurred independently of the health claim (Lawrence, 2006).

2.4.1 Current estimates of folic acid intake from voluntary fortification

FSANZ has estimated the current uptake of voluntary fortification permissions in Australia and New Zealand using the following sources:

• unpublished analytical data for a number of different types of common foods including breakfast cereals, bread and juice (Arcot et al., 2002; Arcot, 2005);

• current label data for foods where no analytical values were available; and
• recipe calculation for foods that contain a folic acid fortified ingredient using estimates of the proportion of these ingredients in a food.

Information from these sources matched against the 1995 and 1997 Australian and New Zealand National Nutrition Survey (NNS) data indicate that 149 foods in Australia and 101 foods in New Zealand were presumably fortified with folic acid.  Foods most likely to be fortified were breakfast cereals and breads.  For foods where a fortified version of the food was not specifically identified within the NNS, but where it is known that a significant proportion of the food category in the market place is now fortified, a folic acid concentration was assigned to the food and weighted to reflect the market share for that food.

The mean intake of folic acid from voluntarily fortified foods among women of child-bearing age is estimated to be 95 µg in Australia and 58 µg in New Zealand.  However, the median[19] intake is much lower in both countries – just 57 µg and 21 µg in Australia and New Zealand, respectively (see Attachment 7).  This indicates that some women in the target population are probably consuming larger amounts of fortified foods (thus increasing the mean intake) whereas a greater proportion are likely to be consuming relatively low amounts (hence the much lower median intake).  The lower mean and median values for New Zealand reflect the lower uptake of voluntary fortification in that country.

In Australia, younger women (15-18 years) have higher median intakes of folic acid from fortified foods (77 µg) than older women (30-49 years) (44 µg) due to higher intakes of breakfast cereals.

2.4.2 Estimated improvement in folate status from voluntary folic acid fortification

Folate status is an indicator of folate intake.  Both serum folate and red blood cell folate are used as measures to reflect folate status.  While serum folate in the individual reflects daily fluctuations in intake, at a population level, (i.e. when the data are aggregated) it is a useful biomarker of folate status.

There have been two regional Australian studies on folate status since the introduction of voluntary fortification.  In Victorian adults aged 15-45 years there was a mean increase in mean serum folate concentrations of approximately 19% for women and 16% for men (Metz et al., 2002c; Metz et al., 2002e) and a Perth study involving adults aged 27-77 years reported a 38% increase in mean serum folate between 1995-96 and 2001 (Hickling et al., 2005e).  

There are no New Zealand studies examining changes in folate status since the introduction of voluntary fortification in that country.      

2.4.3 Estimated reduction in neural tube defects from voluntary folic acid fortification

In Australia, South Australia, Western Australia and Victoria are the only States with good quality data on terminations.   Falls in NTD rates of between 10-30% have been reported by these States (Lancaster and Hurst, 2001; Bower, 2003b; Victorian Perinatal Data Collection Unit, 2005) since the introduction of voluntary fortification.

Although there has been an overall fall in the incidence of NTDs in Western Australia, the disparity between the incidence of NTDs among Indigenous populations and that of the non-Indigenous population in this state has increased over time (Bower et al., 2004).

There are no data on trends in NTD incidence in New Zealand.

2.5 Summary of the current approach to increasing folate intake

There are limited data about the impact of voluntary folic acid fortification on health outcomes.  In Australia, some States with good case ascertainment have reported a fall in the incidence of NTDs since the implementation of voluntary fortification.  Among selected population sub-groups there has also been an apparent rise in serum folate status.  There are no data on trends for either of these indicators in New Zealand.  Since the introduction of voluntary folic acid fortification there have been modest increases in mean intake of folic acid from fortified foods among women of child-bearing age in both Australia and New Zealand.  These increases have occurred despite the variable uptake by industry of voluntary permissions but do suggest that voluntary fortification has had an impact on reducing the NTD rate in Australia in recent years. 

This variability demonstrates the inherent uncertainty in voluntary fortification.  Although voluntary fortification can contribute to achieving public health objectives, the nature of voluntary fortification is such that manufacturers can choose whether to take up fortification permissions, and whether to continue to fortify products over time.  

Similarly, extension of voluntary fortification permissions to other foods would, in theory, provide more folic acid in the food supply, but the level of fortification permission uptake into the future is impossible to predict.  So although modest increases in folic acid intakes have been achieved through voluntary fortification there is no reason to expect that extension of voluntary folic acid fortification would present more certainty than the current approach, with regard to equity, efficacy, predictability and sustainability of the folic acid intake of the target population.

Confounding the impact of voluntary fortification is the impact of supplement intake on NTD incidence.  Western Australia reports that only about 30% of women with healthy babies have taken supplements, despite a sustained campaign promoting supplement usage in that State over many years.  Consequently, supplement usage at a national level among women of child-bearing age is not likely to be high.  The limited data in New Zealand on the use of folic acid supplements restricts any comparison.

3. The Health Issue

In order to establish the regulatory response, the health issue under consideration needs to be clearly stated. 

Neural tube defects (NTDs) are serious birth defects.  Although the majority ( about 70%) of pregnancies affected by an NTD will result in a late stage-termination (usually after 20 weeks), infants born with an NTD will either be stillborn, or in the case of spina bifida in particular, have minor to severe health problems.  Live born infants with anencephaly or encephalocoele comprise only a small proportion of those with NTDs who survive beyond one year of age.

There is convincing evidence that increased folic acid intake among women of child-bearing age from supplements and/or fortified foods can reduce the risk of NTDs.

Various education initiatives have been undertaken to encourage women of child-bearing age to increase their dietary folate intake and take folic acid supplements.  Despite these campaigns, current advice for supplemental folic acid is not followed by a majority of women in the target group.  Reasons for this include:

• lack of knowledge among women about the benefits of folic acid;
• knowledge not always equating to behavioural change; and
• barriers to regular supplement use at the recommended dose, such as cost and access.

A significant issue in relation to supplementation is the fact that approximately half of all pregnancies are unplanned and the neural tube develops before a woman would know she is pregnant.

Voluntary fortification of certain foods with folic acid was first permitted in Australia in 1995 and in 1996 in New Zealand.  Since that time it has resulted in modest increases in folic acid intake among women of child-bearing age.  This is due primarily to the variable uptake by industry of the voluntary permissions, particularly in New Zealand. 

Some States in Australia, with good quality data collection systems, have reported a fall in the NTD rate since voluntary fortification was introduced.  While not all NTDs can be prevented, there are indications that the proportion of pregnancies affected by an NTD can be further reduced.

Internationally, a number of countries have reported successful mandatory folic acid fortification programs as an equitable and sustainable means of increasing the folic acid intake of women of child-bearing age and thereby reducing the incidence of NTDs.

4. Objectives

The specific objective of this Proposal is to reduce the incidence of NTDs in Australia and New Zealand through mandatory fortification of the food supply with folic acid.

The goal is to reduce the incidence of NTDs to the maximum extent possible by increasing dietary folic acid intakes in women of child-bearing age (the target population).  The prime focus for achieving a reduction in this risk will be to increase the folic acid content of the food supply.

The health benefits and risks to the non-target population from increased folic acid intake are considered in making this determination.

In developing or varying a food standard, FSANZ is required by its legislation to meet three primary objectives which are set out in Section 10 of the FSANZ Act 1991.  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 Ministerial Council.

RISK ASSESSMENT of mandatory fortification

This risk assessment quantifies the NTD-related benefit that can be expected from a program of mandatory fortification of food with folic acid in Australia and New Zealand and considers other potential health benefits and risks for the population as a whole from an increase in the dietary consumption of folic acid.

To do this, a number of experts were commissioned to carry out literature reviews of benefits and risks and these are identified in the following discussion.  The completed reviews were subsequently peer reviewed.  A compilation of the main findings from the reviews is provided at Attachment 6 and the full text of the literature reviews is available at www.foodstandards.gov.au.  An expert scientific group was also convened to obtain advice on a series of questions that arose during the initial assessment process.

To assess the impact of mandatory fortification on the target population and the population as a whole, a comprehensive dietary intake assessment has been undertaken based on the universal addition of folic acid to bread (see Attachment 7a).  At Draft Assessment, a dietary intake assessment of mandatory folic acid fortification of bread-making flour was undertaken and this has been included at Attachment 7b.  Comments and additional references have been considered and the risk assessment at Final Assessment has been amended, as appropriate.

5. What are the potential health benefits, particularly regarding rates of NTDs, and potential health risks from increases in folic acid intake?

The following section includes a discussion of the potential health benefits and risks associated with increased folic acid intake.  Where data are available the benefits and risks arising from the international experience of mandatory folic acid fortification are discussed.  Discussion on the benefits and risks associated with the proposed level of mandatory fortification in Australia and New Zealand is included in Section 7.

The potential health benefits and risks of increased folic acid intake are discussed in greater detail in Attachment 6.

5.1 Neural tube defects

There is convincing evidence from both cohort studies and randomised controlled trials that increased folic acid intake at doses ranging from 400-4,000 µg/day and a related increase in folate status reduces the risk of occurrence and recurrence of having a pregnancy affected with an NTD (MRC Vitamin Study 1991; Czeizel and Dudas 1992; Berry et al., 1999; Lumley et al., 2001).  

5.1.1 Experience in other countries following mandatory fortification

Significant falls in NTD rates have been attributed to the introduction of mandatory folic acid fortification in countries such as Canada, the United States and Chile (Table 2).

In Canada, rates of NTDs have fallen markedly, ranging from 49-78% in different provinces with the extent of the reduction being inversely correlated with the pre-fortification NTD rate.

In the United States, rates of NTDs have fallen by 27% although the analysis underpinning the introduction of mandatory fortification predicted a reduction of 41% (see Attachment 4).

In addition to a decline in incidence and birth prevalence of NTDs, researchers in the United States have also recently reported improved first-year survival of infants born with spina bifida post-fortification; possibly due to the potential role of folic acid in reducing the severity of those NTDs that still occur (Bol et al., 2006).

Following the introduction of mandatory fortification in the United States, folic acid intake is estimated to have increased by more than 200 µg/day (Choumenkovitch et al., 2002; Quinlivan and Gregory, 2003) compared with the projected average increase in intake of 70-130 µg /day (USFDA 1993).  As a result, the mean serum folate levels in all age and sex groups have more than doubled (Dietrich et al., 2005c).  Folic acid supplement use remains relatively unchanged (USCDC, 2004).  Despite improvements in folate status across the whole population, low red blood cell folate is still prevalent in non-Hispanic blacks (about 21%) (Ganji and Kafai, 2006c).

The greater percentage decline in Canada compared with the United States reflects the higher baseline NTD rates in Canada at the time mandatory fortification was introduced. 

There are limited data from Canada to indicate if mandatory fortification has also led to a substantial increase in folate status in those provinces with previously high rates of NTDs.  The exception is Ontario, Canada, where Ray et al. (2002a) reported a mean increase in folate status (measured as mean red cell folate) of 41% since mandatory fortification was introduced.

In Chile, the birth prevalence rates for spina bifida and anencephaly have halved.  Induced pregnancy terminations, which are illegal in Chile, were not reported.

5.1.2 Comparative rates for Australia and New Zealand

Between 1999 and 2003, the incidence of NTDs in Australia (based on reported rates in Victoria, South Australia and Western Australia) was 1.32 per 1,000 total births (Bower and de Klerk, 2005[20]).  Voluntary fortification is likely to have contributed to this fall, particularly as the contribution of folic acid supplement appears limited.  These rates are similar to the pre-fortification rates in the United States and Ontario, Canada.

In New Zealand, the birth prevalence is estimated to be 0.66 per 1,000 (including live births and stillbirths, but not terminations).  From 2004 onwards New Zealand has been collecting data on terminations although these data have yet to be reported.

Table 2:  NTD rates in Canada, the United States and Chile: pre- and post-mandatory fortification compared with Australian NTD rates

(a) NTD rates are spina bifida and encephalocoele only.

‘na’ – Not applicable; ‘-’ No data available; * Incidence (i.e. includes terminations); ** Birth prevalence

Sources:

1. Bower and de Klerk, 2005 (The Australian rate is extrapolated from the NTD rate for Victoria, South Australia and Western Australia).

2. Minister of Government Services and Public Works (2000).

3. Liu et al. (2004b).

4. Persad et al. (2002).

5. Ray et al. (2002b).

6. USCDC (2004).

7. Honein et al. (2001).

8. Lopez-Camelo et al. (2005a).

In summary, there is strong evidence from other countries that have introduced mandatory fortification that increases in intake of folic acid up to 200 µg/day are associated with significant reductions in the incidence of NTDs.  The extent of the fall in incidence appears to depend on the prevailing background rate of NTDs prior to fortification.

5.2 Masking of the diagnosis of vitamin B12 deficiency

It has been suggested that high folic acid intakes (>1,000 µg per day) could delay the diagnosis and eventual treatment of severe vitamin B12 deficiency in older people (Capra et al., 2005[21]).  This could occur by correcting the anaemia that may accompany vitamin B12 deficiency which is one of the clinical signs traditionally relied on for diagnosis. 

Recent surveys conducted in Australia and New Zealand show a small to moderate prevalence of vitamin B12 deficiency among older people.  Six to twelve per cent of those surveyed were classified as deficient and a further 16-28% classified as at risk of deficiency or marginally deficient (Flood et al., 2004b; Green et al., 2005b).  Information as to whether those found to be deficient had associated haematological or neurological sequelae was not collected, however, they had not been previously suspected of being vitamin B12 deficient. 

Vitamin B12 deficiency in older people is mainly due to a reduced capacity to release vitamin B12 from food sources (such as foods of animal origin, in particular red meat, dairy foods and eggs, but also foods fortified with vitamin B12 such as soy-based beverages and some yeast extracts) during digestion, or alternatively as a result of malabsorption of free vitamin B12 from the gut caused by gastrointestinal dysfunction.  Very little deficiency in this age group is caused by inadequate dietary intake.

Vegetarians are also at risk of vitamin B12 deficiency due to a reduced vitamin B12 intake; vegans more so than lacto-ovo vegetarians because of a complete absence of animal products in vegans’ diets.  Hokin and Butler (1999a) report that serum B12 levels in 11 vegan Australian Seventh Day Adventist ministers was not different from serum B12  levels in non-vegan vegetarian ministers.  There are no data on the prevalence of vitamin B12 deficiency among vegans in Australia or New Zealand (Capra et al., 2005). 

Vitamin B12 deficiency may take decades to develop in adults and affected individuals may be asymptomatic or may present with a wide spectrum of haematological, neurological and/or psychiatric signs and symptoms.  Vitamin B12 deficiency is recognised through presentation of clinical signs of abnormal haematology or neuropathy and a definitive diagnosis is usually obtained from serum vitamin B12 levels.  Doctors are advised to consider vitamin B12 deficiency as a possible cause when presented with individuals who have clinical signs of anaemia or neuropathy. 

The UL for folate (1,000 µg per day of folic acid) in adults has been set based on the potential to mask the diagnosis of vitamin B12 deficiency and the potential to exacerbate the related neurological symptoms (Institute of Medicine, 1998).  However, the UL incorporates a fivefold margin of safety and intakes of folic acid above the UL are rare from fortification alone (see Section 7.2.2).

Among countries that have introduced mandatory fortification with folic acid, there have been no reports of adverse effects on neurological function, especially in people aged 65 years and over with low vitamin B12 status (SACN, 2005).

5.2.1 Effects of exceeding the upper level of intake (UL) for individuals who are not vitamin B12 deficient

In the absence of vitamin B12 deficiency, there is little information on adverse effects which may occur at levels about the UL.

The UL set for adults has been applied to younger age groups on a relative body weight basis. However, vitamin B12 deficiency is rare in children, and so the relevance of this endpoint and hence the risk to children is not clear.  Due to their lower body weight and their consumption of more food per kilogram of body weight when compared to adults, children are more likely to exceed the UL for folic acid if staple foods are fortified.

In the United States, post mandatory fortification, approximately 15-25% of children aged 1-8 years were estimated to have folic acid intakes above the UL (some up to 2-3 times the UL) and 0.5-5% of adults were estimated to consume >1,000 µg of folic acid/day (Lewis et al., 1999b).  

No adverse effects have been reported, although it is unclear if any surveillance is being undertaken, particularly as there was no commitment at the time mandatory fortification was introduced in the United States to monitor adverse health outcomes (Rosenberg, 2005).   

5.3 Cardiovascular disease

Low folic acid intake increases total plasma homocysteine and high levels of homocysteine can damage the inner linings of arteries.  Consequently, increased folic acid intake, because of its ability to lower homocysteine, has been investigated for its potential to lower cardiovascular disease risk (including heart disease and stroke) and early evidence strongly supported this association.

More recent evidence, however, from several large trials and some smaller randomised controlled trials all concluded that high folic acid doses (1 mg or more per day) did not reduce cardiovascular disease risk (see Attachment 6).

5.4 Cancer

Folate acts as a methyl donor in the synthesis of purines and ultimately DNA and therefore could affect the development of cancer.  A number of epidemiological studies have suggested that people with higher folate intakes have lower rates of various cancers.  An alternative hypothesis is that folate might increase progression of pre-cancerous lesions but lower the risk of cancer if no lesion exists. 

The association between folate and cancer has been investigated as part of the development of this Proposal in relation to the incidence of all cancers, prostate cancer, breast cancer and colorectal cancer.  A summary of the findings from these studies is provided below (also see Attachment 6).

5.4.1 Total cancer

Two recent and large trials investigating the association between folic acid and cardiovascular disease, also reported total cancer incidence among their study participants.  A meta-analysis of the results yielded a non-significant increase of 5.6% (95% CI: 0.91-1.23) in the incidence of total cancer.  Both trials involved folic acid supplements; in one, the dose was 2.5 mg of folic acid and in the other 800 µg.  There are other similar trials underway which will add to the evidence base and possibly clarify the role, if any, of folic acid and cancer.

5.4.2 Prostate cancer

One trial and three cohort studies found no significant association between serum folate levels and incidence of prostate cancer.  A large Swedish study, however, did observe a significant association between higher serum folate levels and increased risk of prostate cancer but only among study participants with a particular genetic make-up.  In this study, ‘higher’ folate levels were below the pre-voluntary fortification mean in a Perth cohort.

Based on these findings, and the lack of intake studies, the evidence base is not sufficient to draw a conclusion about the relationship of folic acid and increased risk of prostate cancer.

5.4.3 Breast cancer

Results from five recently reported cohort studies investigating folate intake from diet and supplements and from one intervention trial collectively indicate no effect between folate intake and breast cancer risk.  Eight case-control studies and one case-cohort study found mixed results, although three of these reported a protective effect among women at greater risk of breast cancer because of higher alcohol consumption.

Fewer studies have examined the relationship between blood folate levels and incidence of breast cancer but no significant associations have been reported.

These findings indicate that folic acid is not associated with an increased risk of breast cancer (and may reduce the risk among heavy consumers of alcohol).

5.4.4 Colorectal cancer

A 2005 meta-analysis investigating the effect of folate on colorectal cancer found an overall protective effect or no effect based on separate analyses of four different categories of studies including cohort and case-control studies.  More recently published results (four cohort studies and one trial) report a slight increase in risk or a slight decrease with higher total folate intake and two studies using serum folate levels as indicators of folate intake reported conflicting results.

In summary, the more recent studies do not alter the conclusion from the 2005 meta-analysis that total folate intakes do not increase the risk of colorectal cancer.

5.4.5 Conclusion

Two large trials using much higher doses of folic acid than is proposed under mandatory fortification do not indicate a gradient of risk for total cancers.  For the three specific cancer sites examined, the results of more recent studies do not alter the conclusion reached in earlier reviews (SACN, 2004; SACN, 2005; Sanjoaquin et al., 2005f) that there is no apparent increase in risk associated with higher folic acid intakes for the population as a whole.  Although many of the studies suggest that some reduction in cancer might occur, most of these are observational and so might be affected by uncontrolled confounding by other factors.

5.5 Cognitive function

Earlier observational evidence suggested an association between low folate levels and increased risk of cognitive decline, dementia and Alzheimer’s Disease.

More recent evidence from two studies published early in 2006 report no association between increased folic acid intake or increased serum folate and improved cognitive functioning.  In one of the studies, lower red blood cell folate was, however, associated with poorer cognitive performance.

These findings are, however, not sufficient evidence to conclude that low folate levels are associated with cognitive decline.

5.6 Unmetabolised circulating folic acid

The potential impact of an increased intake of synthetic folic acid on unmetabolised circulating folic acid with suggestions of adverse health consequences is only just emerging in the scientific literature.  The scientific discussion around this matter is not well developed, and cannot therefore be used to inform the assessment of risks associated with folate fortification.

5.7 Other effects during pregnancy

The evidence is inconclusive for an association between increased folic acid intake and increased risk of multiple births.  Multiple births result in more complications and poorer outcomes than singleton births. 

The evidence is inconclusive for a positive effect on birth weight or Down Syndrome from increased folic acid intake.

5.8 Other potential health risks

Other potential health risks from increased folic acid intake in the total population have also been reported in the literature.  These include the likelihood of:

• folate-drug interactions;
• interactions with zinc status; and
• a negative impact on the gene pool.

Although, there is the potential for an increased folate intake to interfere with certain medications, available scientific evidence has not demonstrated any clinically significant interaction with therapeutic medicines from folate intakes up to 1,000 µg/day (Colinas and Cook, 2005[22]).

It is highly unlikely that increases in folic acid intake associated with mandatory fortification would have a negative impact on zinc status in the Australian and New Zealand populations.

One recent paper postulates that an increased folate status in the population is potentially associated with a negative impact on the gene pool.  Whilst this is a possibility, this potential outcome does not differ from other interventions that seek to prolong the life of children affected by serious genetically inherited childhood diseases or conditions.

6. What is an appropriate food vehicle and what level of folic acid intake can be achieved among women of child-bearing age using mandatory fortification?

This section describes the rationale for the selection of the food vehicle(s) and the safety and technical issues associated with adding folic acid to the food vehicle.  It also describes various fortification scenarios aimed at maximising folic acid intake to the greatest extent possible among women of child-bearing age based on recommended target levels while ensuring that there is no additional health risk to the population as a whole, including young children.  

6.1 Selection of food vehicle

At Draft Assessment, FSANZ drew on international experience in narrowing the range of food vehicle options for mandatory folic acid fortification.  In the majority of countries mandating folic acid fortification, flour has been selected as the food vehicle. 

Guidance on the suitability of potential food vehicles for fortification is also provided by published international criteria (Codex Alimentarius Commission, 1991; Darnton-Hill, 1998; Nutrivit 2000).  These criteria include the need for the selected vehicle(s) to:

• be regularly consumed by the population at risk in stable, predictable amounts (upper and lower intake levels known);
• be available to the target population regardless of socio-economic status;
• supply optimal amounts of micronutrient without risk of excessive consumption or toxic effects;
• retain high level stability and bioavailability of the added micronutrient under standard local conditions of storage and use;
• be economically feasible;
• be centrally processed so that quality control can be effectively implemented; and;
• not interact with the fortificant or undergo changes to taste, colour or appearance as a result of fortification.

Bread-making flour (consumed as bread and bread products) was considered to be a technically feasible vehicle due to the existing mandatory fortification requirement with thiamin in Australia.  However, industry expressed considerable concerns at the high degree of impost and technical difficulties associated with fortifying bread-making flour as part of the flour milling process, to the required standard.  For example, the level of precision required to meet the proposed range of folic acid amounts to be added.  Additionally, the New Zealand milling industry indicated that segregation of bread-making flour would be prohibitively expensive because of the lack of infrastructure.  On the basis of New Zealand industry’s inability to segregate flours, concerns were also raised about the lack of choice for consumers to select non-fortified flour-based products and the resulting impact on population-wide increases in folic acid intakes beyond that intended through mandatory fortification.

In response to these issues, FSANZ considered alternative mechanisms for delivering folic acid into bread.  Industry was canvassed from March 2006 on other means of adding folic acid during the bread-making process, for example in bread improvers, and yeast.  At that time industry representatives asserted the addition of folic acid during the bread-making process presented a number of practical difficulties.

FSANZ subsequently sought additional information on alternative mechanisms from a consultant engaged in June 2006 to investigate the feasibility of adding folic acid in the bread-making process as well as advice from the Australian and New Zealand milling and baking industry.

More recent advice from the New Zealand industry has indicated that addition of folic acid during the bread-making process is feasible and provides greater control over the level of fortification going into the product.  This has since been confirmed by FSANZ’s consultant (see Attachment 10, Appendix 1).

Given the potential for New Zealand consumers to exceed safe folic acid intakes from a broader than intended range of products, it was important to explore alternate means to limit this possibility.  Furthermore, the requirement to fortify bread with folic acid, rather than mandating where in the manufacturing process fortification was to occur, was seen as providing a more flexible outcome for industry, particularly in New Zealand, where bread-making flour is currently not fortified with thiamin.

Consequently, following further consultation, FSANZ has refined the approach at Final Assessment to require the mandatory fortification of bread.  The mechanism for delivering the folic acid to the bread, however, has no longer been specified. 

6.1.1 The suitability of bread as the selected vehicle

Bread is defined in Standard 2.1.1 – Cereals and Cereal Products of the Code as:

the product made by baking a yeast-leavened dough prepared from one or more cereal flours or meals and water.

This definition therefore includes the following products: bread and bread rolls, sweet buns, fruit bread, English muffins, bagels, yeast leavened flat breads and breadcrumbs. 

Bread is widely and regularly consumed by the target group consistent with the first of the above criteria.  Evidence from national nutrition surveys conducted in the mid to late 1990s indicates that 85% of Australian and 83% of New Zealand women of child-bearing age consume bread (a fall of just 3% of women in the target group who consumed products containing bread-making flour).  This level of consumption has been supported by more recent survey data.  Bread is therefore a staple, relatively low cost food regularly consumed by the majority of the target population.

Further analysis undertaken by FSANZ as part of Final Assessment also indicated that there are very few differences in the amount of bread consumed or folic acid intakes among women of child-bearing age from different socio-economic groups.

6.1.1.1 Australian Indigenous consumption of bread

Separate analyses by Indigenous identification are not possible because Indigenous people make up only 2% of the population and they were not over-sampled in the Australian 1995 NNS. 

Slightly more than one-half of the Australian Indigenous population lives in areas that are classified as ‘major cities’ or ‘inner regional areas’.  As such, they have access to the supermarkets and corner stores that serve the populations of these areas. 

One-quarter of the Australian Indigenous population live in areas classified as remote or very remote and have restricted access to a wide range of shopping facilities.  A survey of remote community store managers, most from the Northern Territory and some from Western Australia, were asked to nominate their 20 top selling items.  Seventy-eight items were identified from the 18 store managers that responded.  Bread was nominated by 17 of the 18 stores and achieved an average position of 6.1 in the list.  By contrast, flour was nominated by only seven managers and had an average position of 10.4 in the list (DHCS, 2005). 

Therefore the proposed strategy of fortifying bread would reach Indigenous populations in remote areas where folate status may be poorer. 

6.1.2 Stability of folic acid added to bread

There are two key issues to consider in reviewing the stability of added folic acid: stability during storage and during processing (e.g. baking).  Folic acid added to food is stable to a variety of processing and storage conditions.  In contrast, natural folate is relatively unstable.  Naturally occurring folates are easily destroyed during harvesting, storage, processing and preparation.  Up to 75% of natural folate may be lost due to these processes (McKillop et al., 2002). 

6.1.2.1 Storage losses in flour

Generally, the retention of folic acid is high during storage.  Studies during the 1970s indicated that folic acid mixed with flour is stable (100% retention) after six months at room temperature or four weeks at 45°C.

Even after one year of storage at around 45°C, flour showed only small losses.  Similarly, retention was 90-100% in pre-mix fortified yellow corn (NHMRC, 1995).  A 1995 study in which folic acid was added at either 100 µg/100 g or 500 µg/100 g of flour showed around 100% retention at a range of temperatures (-23 to 48.8°C) after one year’s storage (Morgan, 1996).

6.1.2.2 Processing losses

The average loss of folic acid from bread made with fortified flour appears from the literature to be about 25% but may be as high as 40%.  To account for these losses in fortified flour, millers would apply an overage of 1.33 to 1.67.

In a study that examined sweet biscuits, the mean loss of folic acid in the biscuits was 15% under optimal conditions.  In another study on crackers, mean loss was 7.2% (with a maximum of 15.3%) (NHMRC, 1995). 

Further detailed discussions on the technical aspects of the chosen food vehicle, bread, are in the Food Technology report (see Attachment 10).

6.1.3 Bioavailability of folic acid

Bioavailability refers to the ability of the body to extract, absorb, and metabolise nutrients in food.  The bioavailability of folate is not fully understood and there appear to be a number of factors that influence it. 

It is difficult to predict the bioavailability of folate (both naturally-occurring and synthetic forms) from a mixed diet, based on studies of individual foods (Gregory, 1995; Brouwer et al., 2001; Sanderson et al., 2003).

Factors that influence folate availability from food include:

• composition of the food matrix (including the presence of antagonistic components most notably organic acids binding to other food components and encapsulation within plant cells leading to reduced exposure to digestive enzymes); 
• amount of folate consumed;
• chemical form of folate; and
• host-related factors including nutrient and health status and genetic factors.

The bioavailability of naturally-occurring folates is thought to be only 50-60% while folic acid, used to fortify foods or as a supplement, is thought to be about 85% bioavailable.  On this basis, folic acid added to bread is expected to have a similar bioavailability.  A substantial increase in the folate status of populations exposed to mandatory folic acid fortification reflects its bioavailability[23].  Folic acid consumed as a supplement is almost 100% bioavailable on an empty stomach (NHMRC and NZMoH, 2006).

6.2 Dietary targets

The recommendation for women of child-bearing age to reduce the risk of having an

NTD-affected pregnancy is 400 µg/day of folic acid from supplements or fortified foods, which equates to 670 µg DFEs, in addition to food folate (NHMRC and NZMoH, 2006). 

While it is desirable to maximise the proportion of women who achieve this level of intake, the variability in intake among this group and in other population sub-groups limits the extent of folic acid fortification without a significant proportion of other population sub-groups exceeding the UL.

6.3 Fortification scenarios

In assessing the introduction of mandatory fortification of food with folic acid in Australia and New Zealand, a dietary intake assessment (see Attachment 7a) was conducted to compare the increase in folic acid intakes from the current voluntary permissions to the proposed mandatory fortification of all breads.  The dietary intake assessment undertaken at Draft Assessment involving the mandatory addition of folic acid to all bread-making flour is at Attachment 7b.

The following two fortification scenarios are used as the basis for this comparison:

• ‘Baseline’ - Current folic acid intakes from foods voluntarily fortified[24]; and
• ‘Scenario 1’ (Preferred scenario at final assessment) - ‘Baseline’ (except bread) + the introduction of mandatory fortification of all bread at 135 µg/100 g.

The dietary intake assessment scenarios did not take into account naturally-occurring folate in food.  There is little evidence to support naturally-occurring folate as protective against NTDs (Green, 2005[25]). 

The NHMRC recommendation of 400 µg per day to reduce the incidence of NTDs is based on additional folic acid from fortified foods or supplements and the model used in this Proposal to estimate the number of NTDs reduced from the introduction of mandatory fortification (see Section 7.1) is underpinned by incremental increases in folic acid intake.

The estimated intakes of folic acid from both fortified foods and folic acid supplements are discussed in Section 6.7.2.

6.4 Assessment of baseline folic acid intakes

For both Australia and New Zealand, ‘Baseline’ folic acid intakes were assessed using folic acid concentration data from analytical programs, current food labels and recipe calculations where foods contained a known folic acid fortified food as an ingredient (see Section 2.4.1).  Label concentrations were not adjusted for under- or overage of folic acid as there was insufficient information available on which to reliably assess the extent of such under- or overages.  Where information on natural folates was available, this was used to adjust the declared label folates value to estimate added folic acid.

6.5 Selection of folic acid concentrations

At Draft Assessment, a residual level of 200 µg of folic acid per 100 g of bread-making flour was the preferred option.  This equates to a concentration of 120 µg/100 g in the average loaf of bread.  Based on this estimate, folic acid concentrations of between 100-170 µg of folic acid per 100 g of bread were modelled with the aim of achieving the same level of effectiveness and safety.

Thus, at Final Assessment, the selected folic acid concentration is 135 µg of folic acid per
100 g of bread.

6.7 Dietary intake assessment for women of child-bearing age

6.7.1 Estimated folic acid intake from fortified foods

6.7.1.1 Baseline

It is estimated that Australian women aged 16-44 years are currently consuming about 95 µg of folic acid per day from food voluntarily fortified.  In New Zealand, the amount is less due to the lower uptake of voluntary fortification in that country; about 58 µg per day among the target group.

In estimating the impact of mandating folic acid fortification, it has been assumed that the intake of folic acid from voluntary fortification remains constant.

6.7.1.2 Preferred scenario at Final Assessment

If intakes from voluntary fortification remain unchanged (‘Baseline’) then fortifying all bread at 135 µg/100 g results in an estimated mean intake of folic acid from fortified foods of
196 µg per day in Australia and 198 µg per day in New Zealand among women of child-bearing age. 

However, even with this additional intake, just 4% of women in Australia and 2% in New Zealand would meet the recommended intake of 400 µg of folic acid per day from fortified foods. 

6.7.1.3 Preferred scenario at Draft Assessment

The preferred scenario at Draft Assessment indicated that fortifying all bread-making flour at residual levels of 200 µg/100 g would result in an estimated mean intake of folic acid from fortified foods of 195 µg per day in Australia and 189 µg per day in New Zealand among women of child-bearing age.  This additional intake resulted in 5% of women in Australia and 2% in New Zealand meeting the recommended intake of 400 µg of folic acid per day from fortified foods. 

A comparison of the two scenarios is provided in Table 3 which shows that both result in very similar mean increases in folic acid intake among the target population.

Table 3:  Comparison of estimated mean folic acid intake for women of child-bearing age* from the mandatory fortification of all bread or all-bread-making flour

* Women aged 16-44 years.

6.7.2 Estimated folic acid intake from fortified foods and supplements

Additional calculations were conducted to estimate folic acid intakes for women of child-bearing age who consume a folic acid supplement as well as fortified food.  Supplements containing folic acid concentrations of 200 µg (Australia and New Zealand), 500 µg (Australia only) and 800 µg (New Zealand only) were selected because folic acid supplements containing 500 µg of folic acid are widely available in Australia, whereas in New Zealand, 800 µg of folic acid supplements are recommended (see Section 2.1.2).  In addition, a daily supplement containing 200 µg was selected on the basis of a recent study (Bower et al., 2005).

When women receive 200 µg of folic acid per day from supplements in addition to fortified foods, their mean intake is only slightly below the recommended 400 µg of folic acid per day.  To achieve 400 µg of folic acid per day a woman could consume one 40 g serve of voluntarily fortified breakfast cereal (containing 120 µg folic acid) + two slices of bread (weighing 60 g and therefore containing 81 µg based on a fortification level of 135 µg/100 g of bread) + a supplement containing 200 µg of folic acid.  If supplements containing 500 µg (in Australia) and 800 µg (in New Zealand) are taken daily mean intakes increase substantially (Table 4).

It should be noted that these estimated folic acid intakes assume all females 16-44 years receive additional folic acid from folic acid supplements, which although unlikely to occur, highlights the resulting outcome if universal supplementation prevailed.  

Table 4:  Estimated folic acid intakes among women of child-bearing age* from fortified foods and supplements for Australian and New Zealand

* Women aged 16-44 years.

6.8 Robustness of the estimates used to determine bread consumption and folic acid intakes

In response to concerns raised in submissions at Draft Assessment about the age of the data used to undertake the dietary intake assessment (the 1995 Australian National Nutrition Survey and the 1997 New Zealand National Nutrition Survey), FSANZ collated recent data on bread consumption from a variety of sources in Australia and New Zealand.  Although there were difficulties in directly comparing the data due to differences in survey methodologies used, they did indicate that the proportion of the population consuming bread, including the target group, is about 80% in both countries.  This is similar to the proportion determined in the 1995 and 1997 surveys (see Section 6.1.1).  The quantity of bread consumed has also remained the same (about two slices per day).  Attachment 7a provides further details about the surveys considered.

These results support the robustness of the national survey consumption data used to assess folic acid intakes under a mandatory fortification scenario which underpins the assessment of effectiveness and safety of the Proposal and indicates that bread consumption by the target group has not changed significantly in the last decade.

6.9 Alternative approaches to mandatory fortification

In response to submissions received at Draft Assessment, FSANZ assessed two alternative approaches to folic acid fortification.  The first considers restricting the types of breads that are mandatorily fortified to enhance consumer choice and the second considers increasing the types of foods that are voluntarily fortified rather than mandatory fortification of all breads.

6.9.1 Restricting breads that are mandatorily fortified in response to concerns about consumer choice

Four options were considered by FSANZ involving various types of bread and these are compared with FSANZ’s proposed strategy (Table 5).

Table 5:  Per cent of women of child-bearing age* in Australia and New Zealand consuming different bread types

NA - Not assessed.

* Women aged 16-44 years.

** The estimates of consumption by the target group do not include any voluntary fortification permissions. 

# Does not include bread crumbs for New Zealand.

The results clearly indicate that FSANZ’s proposed strategy, involving the mandatory fortification of all breads, will maximise the proportion in the target population consuming folic acid.  Consumer choice will be provided by flat breads that don’t contain yeast and consumers choosing to purchase flour and bread pre-mixes to make their own bread (see Section 9.3 for further discussion on consumer choice).

6.9.2 Increasing voluntary permissions to increase folic acid intake among the target population and minimise folic acid intake among the non-target population

One option considered by FSANZ involved a small expansion to the range of foods currently permitted to be voluntarily fortified.  These foods comprised one brand of low/reduced fat natural yoghurts, some additional breads from one manufacturer and one brand of reduced/low fat/energy frozen meals. 

Because no market share data other than bread was provided the dietary intake assessment assumed that all brands of foods in these categories were fortified, thus overestimating the increases in folic acid intakes. These estimates are compared with FSANZ’s proposed strategy (Table 6).  It was assumed that the market share for breads increased from 15% at Baseline to 20% for this alternative proposal to account for the extra breads that may be voluntarily fortified.  

Table 6:  Estimated mean folic acid intakes among women of child-bearing age* in Australia and New Zealand for different voluntary and mandatory fortification scenarios

* Women aged 16-44 years.

** Additional foods includes some breads across a range of types, all low/reduced fat natural yoghurt and all reduced/low fat/energy frozen meals.

The estimated folic acid intakes do not increase appreciably from Baseline for the alternative voluntary fortification scenario.  This is due to the small number of consumers of low/reduced fat natural yoghurt (~1%), and all reduced/low fat/energy frozen meals (<1%), and because of the small increase in the bread market that is likely.  Thus, the results clearly show that mandatory fortification of all breads with folic acid will maximise intake among the target population.

7. Based on the expected increase in folic acid intake from mandatory fortification what are the likely health benefits and risks?

7.1 Expected reduction in neural tube defects

The number of NTDs that could be prevented for Scenario 1 described in Section 6.7.1.2 has been estimated using an approach recommended by (Wald et al., 2001).  The Wald model is underpinned by a dose-response relationship between folic acid intake and risk of NTDs according to serum folate concentrations (Attachment 9). 

Fortifying bread with folic acid at a concentration of 135 µg /100 g of bread will result in an estimated 14-49 NTD-affected pregnancies being prevented in Australia and 4-14 NTD-affected pregnancies prevented in New Zealand.  This represents a reduction of between
4-14% in Australia and 5-20% in New Zealand (Table 5). 

Table 5:  Estimated number of NTD pregnancies prevented based on adding 135 µg of folic acid per 100 g of bread in Australia and New Zealand

* Estimates of the mean increase in folic acid intake are based on dietary modelling using DIAMOND.

** Estimates of the number of NTDs prevented are based on the approach by Wald et al. (2001) (see Attachment 9). 

As some Indigenous populations in Australia have double the NTD rate (2.56/1,000 total births) compared with the non-Indigenous population (1.32/1,000 total births) (Bower et al., 2006), the fall in NTD incidence among some Australian Indigenous populations may be greater.

It is estimated that up to 70% of NTDs could be prevented through universal use of folic acid supplements (Berry et al., 1999) although the extent of the potential fall is dependent on the folate status of the target population.

The numbers of NTDs have been falling for some years and so the proportion potentially preventable will diminish with time.  Where Australia and New Zealand are currently lying in relation to the potential fall of up to 70% of NTD-affected pregnancies from increased folic acid intake remains unknown.  The available Australian data on the fall in the number of NTDs since the introduction of voluntary fortification is shown in Figure 1.  Lancaster and Hurst (2001) reported the numbers and rates of NTDs in Australia between 1991-95 (pre-fortification) and 1996-97 but concluded that they were likely to be a substantial underestimate; hence the number of pregnancies affected with an NTD pre-fortification remains unknown for this period.  The NHMRC (1995) reported 400-500 NTDs per year nationally based on extrapolation of State-based data.  This period equates to the time voluntary fortification was introduced.  More recently, Bower and de Klerk (2005) reported approximately 340 NTDs per year based on extrapolation of State-based data with good ascertainment rates.  Thus, although a similar increase in mean folic acid intake is expected from mandatory fortification as has been achieved with voluntary fortification to date (about 100 µg), the number of NTDs potentially prevented declines because of the increase in the folate status of the population.

Figure 1:  Decline in numbers of NTD-affected pregnancies since voluntary folic acid fortification was introduced in Australia in 1996

Sources:

1 NHMRC (1995)

2 Bower & de Klerk (2005)

3 Predicted by FSANZ at Final Assessment.

7.2 Health risks to the whole population

To assess health risks that might arise from mandatorily fortifying bread with folic acid, the folic acid intakes of population sub-groups were compared to the appropriate UL.  The health risks to the whole population are discussed in greater detail in Attachment 8.

7.2.1 Comparison of estimated dietary folic acid intakes with the UL

The proportion of each population group exceeding the UL[26] is shown in Table 6. 

Table 6:  Per cent of Australian and New Zealand respondents with folic acid intakes above the UL at Baseline and Scenario 1

* Data from the New Zealand national nutrition survey is only available for ages 15 years and over.

7.2.2 Masking of the diagnosis of vitamin B12 deficiency

7.2.2.1 Young children

Vitamin B12 deficiency is rare in children and so the relevance of the UL and hence the risk to children is not clear.

At all fortification levels, including the Baseline level, Australian children aged 2-3 years were the most likely population sub-group to exceed the UL, due to their relatively higher food consumption on a body weight basis.  However, for Baseline and the mandatory fortification scenario, the percentage of respondents with intakes greater than the UL declined with increasing age. 

Fortifying bread at 135 µg /100 g results in a small percentage of children aged 2-3 and 4-8 years exceeding the UL (7% and 3%, respectively; previously 6% of 2-3 year exceeded the UL based on the Draft Assessment proposal).  Of the small proportion of children that are estimated to exceed the UL following the introduction of fortification at this level all are predicted to have intakes below those which would be expected to cause adverse effects.  That is, these intakes still remain within the margin of safety.  This, combined with the low probability of vitamin B12 deficiency within this age group, suggests that fortification up to 135 µg/100 g bread is very unlikely to put children at risk.   

Based on assessments conducted for New Zealand children external to FSANZ using different methodologies[27] the results indicate that a similar proportion of New Zealand children 5-14 years would exceed the UL compared to Australian children of the same age. 

7.2.2.2 Target group (women 16-44 years)

Only a very small percentage (<1%) of women aged 16-44 years exceed the UL at a fortification level of 135 µg/100 g of bread.  This percentage is unchanged from the percentage of women exceeding the UL at Baseline and unchanged from the percentages exceeding the UL at Draft Assessment.  Thus, there is no additional risk to health among women of child-bearing age from the level of folic acid intakes likely to arise from mandatory fortification.

The percentage of the target group exceeding the UL increases significantly when folic acid intake from supplements is considered, in addition to folic acid from fortified food.  The
800 µg supplement recommended in New Zealand in conjunction with fortified foods could lead to 44% of New Zealand women in the target group exceeding the UL.  However, due to the low prevalence of vitamin B12 deficiency in women of child-bearing age, intakes of folic acid at or above the UL are unlikely to have adverse effects. 

7.2.2.3 Older people

The sub-group most at risk of adverse effects if the UL is exceeded are older people as vitamin B12 deficiency is most prevalent in this group (see Section 5.2.1).  Dietary intake assessment showed none of the individuals aged 70 years and over exceeded the UL at a fortification level of 135 µg/100 g of bread.  Only a very small proportion (<1%) of individuals aged 50-69 years exceed the UL at these fortification levels.  This is unchanged from the percentage exceeding the UL at Baseline and unchanged from the percentages exceeding the UL at Draft Assessment.  Therefore, it is unlikely that at a fortification level of 135 µg/100 g of bread will increase the risk of adverse effects in this population sub-group because of the increased incidence of masking the diagnosis of vitamin B12 deficiency. 

7.2.2.4 Conclusion on masking of the diagnosis of vitamin B12 deficiency

Based on the dietary intake assessment, it is unlikely that fortification of all bread at a level up to 135 µg/100 g of bread will increase masking the diagnosis of vitamin B12 deficiency in either the target or non-target populations.

7.2.3 Uncertainties

In the absence of vitamin B12 deficiency, there is little information on the potential effects (adverse or beneficial) of an increase in folic acid intakes in the general population over the long term.  Data from overseas do not indicate any particular cause for concern at this stage, however, there are significant uncertainties and insufficient evidence to be able to predict all possible outcomes from an increase in folic acid intakes.

There is significant uncertainty around how the use of voluntary fortification permissions might change following the implementation of mandatory fortification.  If the uptake of voluntary fortification increases, intakes of folic acid could be higher than estimated in the dietary intake assessment.  Due to the uncertainty around the impact of increased folic acid intakes on health in the long term, it will be essential to closely monitor all identified potential adverse health outcomes. 

8. Risk assessment summary

In terms of the potential health benefits, there is strong evidence based on international experience of mandatory fortification in countries with pre-fortification NTD rates similar to Australia and New Zealand that mandatory folic acid fortification of bread will further reduce the incidence of NTDs.  The extent of the reduction, however, depends on several factors including the initial folate status of women and the background prevalence of NTDs.

The totality and quality of evidence in support of a protective effect of folate on cardiovascular disease, considered probable for many years, has recently been challenged.  The studies in question, however, have assessed only the secondary prevention of the disease (rather than primary prevention) and involve much higher doses (e.g. 2,500 µg of folic acid per day in capsule form) than would occur with mandatory fortification.

Improvements in cognitive function, considered in early literature as a potential positive benefit associated with increased folic acid intakes, have not been confirmed with more recent and robust scientific investigation.  The evidence is also inconclusive for a positive effect on birth weight, increased risk of multiple births or reduced incidence of Down Syndrome from increased folic acid intake.

In terms of the potential health risks, there have been no reports of adverse effects on neurological function in older people with low vitamin B12 status among countries that have introduced mandatory fortification with folic acid and there are no clinically significant interactions with folic acid intakes up to 1,000 µg/day and therapeutic medicines. 

The results of more recent studies on the incidence of all cancers and cancer of the prostate, breast and colorectum do not alter the conclusion reached in earlier reviews (SACN, 2004; SACN, 2005; Sanjoaquin et al., 2005e) that there is no apparent increase in risk associated with higher folic acid intakes for the population as a whole.  Many of the studies suggest that some reduction in cancer risk might occur, however, most of these are observational and so might be affected by uncontrolled confounding factors.

Despite these conclusions indicating minimal or no risk, it cannot be concluded that mandatory fortification is completely without health risks either from the potential risks described above or uncertainties about health risk such as unmetabolised circulating folic acid from chronic, long-term exposure to significantly higher intakes among the population as a whole, but particularly from childhood onwards.  As a result, a conservative approach to mandatory fortification is recommended.

With this view in mind, the dietary intake assessment indicates that fortification of all bread at a level of 135 µg of folic acid per 100 g of bread will result in an estimated mean increase in folic acid intake in the target population (women aged 16-44 years) of 101 µg and 140 µg per day, in Australia and New Zealand, respectively. 

In response to this anticipated increase in intake, the number of pregnancies affected by an NTD is likely to reduce by an estimated 4-14% in Australia and 5-20% in New Zealand.

As just 4% of women of child-bearing age in Australia and 2% in New Zealand would meet the recommended intake of 400 µg of folic acid per day at this level of fortification, it will be necessary to continue to promote folic acid supplements.  Also, due to the uncertainty of increased folic acid intakes on health in the long term, it will be essential to monitor all identified adverse health outcomes. 

risk management of mandatory fortification

9. Identification of risk management issues

The following section identifies risks, other than the public health and safety risks identified by the Risk Assessment, and discusses associated issues relevant to consideration of mandatory folic acid fortification.  These include social, consumer and economic issues particularly related to the selected food vehicle of bread and where raised in submissions or targeted consultations.

9.1 Technical and industry issues for mandatory fortification

9.1.1 Bread production in Australia and New Zealand

In Australia in 2000-2001, there were around 7,000 establishments involved in baking bread and bread products commercially.  Based on industry estimates, New Zealand has eight major bakery companies with 19 plant bakeries, and between 2,000-3,000 small bakeries.[28]

The bread baking sector can be categorised into four groups: the corporate plant bakeries, independent bakeries and hot bread shops, franchised hot bread shops, and supermarket in-store bakeries [29].  The market share of these groups is presented in Figures 2 and 3 below.

Corporate plant bakeries account for the majority of bread production, and produce bread for wholesale distribution.  Two national bakery companies, Goodman Fielder and George Weston Foods account for 90% of the plant bakery production in Australia, and between 80-85% of the plant bakery production in New Zealand.  Supermarket in-store bakeries, traditional and franchised bakeries and hot-bread shops have on-site bread manufacturing and retailing, and represent a growing sector in the bread industry, with franchised hot bread shops representing the fastest growing sector of the Australian baking industry.

Figure 2:  Australian Bread sector Market Share[30]

Figure 3:  New Zealand Baking Sector Market Share[31]

Bread is produced using one of the following three general methods:

• ‘from scratch’ baking, where individual ingredients are weighed out and assembled for each batch of bread dough;
• premixes[32], to which flour, water, yeast and salt are usually added.
• frozen dough, where dough produced at a bakery site is on sold in a frozen state, for subsequent proving and baking by the purchaser.

Plant bakeries and a small proportion of independent bakeries, particularly artisan bakeries, characteristically produce bread ’from scratch’.  Premixes of bread ingredients are widely used by in-store supermarket bakeries, hot bread shops, and some independent bakeries and franchised hot bread shops. 

Frozen dough is used in some in-store supermarkets, and is widely used in fast food outlets providing bread ‘baked on the premises’.

9.1.2 Bread and bread products

Apart from bread loaves, the bread sector produces a range of products, which include English muffins, rolls and buns, specialty bread, flat bread and breadcrumbs.  It is therefore important to ensure that the bakery products required to be fortified under a mandatory fortification standard are clearly differentiated.

Bread is defined in Standard 2.1.1 – Cereals and Cereal Products of the Code as:

the product made by baking a yeast-leavened dough prepared from one or more cereal flours or meals and water.

This definition therefore includes the following products: bread and bread rolls, sweet buns, fruit bread, English muffins, bagels, yeast leavened flat breads and breadcrumbs.

FSANZ will prepare an Implementation Guide to assist industry in complying with the mandatory standard.  This will include guidance on identifying products which will be required to be fortified with folic acid.

9.1.3 Bread fortification methods

The method of adding folic acid to bread to meet the mandatory fortification requirement will vary according to bakery production methods, and quality control systems in place.  Possible points of addition are:

• flour fortified with folic acid;
• single dry bread ingredient such as a bread improver[33] fortified with folic acid;
• complete premix of dry minor and micro ingredients which has been fortified with folic acid; or
• folic acid vitamin premix which is added to the dough with other dry minor and micro ingredients.

Both bread improvers and premixes are added to the bread ingredients on a weight basis in a batch system, and present a precise means of achieving fortification of bread with folic acid.  Similarly, the use of a specific folic acid vitamin premix where the amount of folic acid is matched on a weight basis to the bread produced will also give a high degree of precision in fortification[34].  However, in bakeries where the level of improver or premix used varies from the manufacturer’s recommendation, there may not be a consistent fortification level in bread production.  The widespread use of bread improvers and premixes in the baking industry provides a controlled method of folic acid fortification for independent and in-store bakeries.

9.1.4 Range of addition

An additional consideration is the industry practice of ‘overages’ when adding vitamins and minerals to foods.  This is where manufacturers usually add more nutrients to account for losses during processing and storage.  Where no maximum is established, the actual amounts added can be considerably higher than the minimum required in the purchased food.  This was the experience in the United States after mandatory folic acid fortification was introduced (see Attachment 4).  The Australian milling industry have also indicated that over-fortification of thiamin estimated at 100% or greater, which is mandatorily added to bread-making flour in Australia, may occur during flour milling[35].  The usual practice of ‘overages’, suggests that applying a range rather than setting a minimum will reduce the likelihood of greater than desired levels of fortification.

9.1.5 Baking industry capacity for mandatory folic acid fortification

Because of the variation in bakery sizes, production methods and technical expertise available, individual bread manufacturers will make decisions as to the most suitable and cost effective method of folic acid fortification for their particular bread production site.

Plant bakeries, in-store supermarket bakeries and bread franchises will have access to technical support staff with the necessary expertise for decisions relating to achieving the best method of addition of folic acid to their bread products, and the correct level of folic acid.  Independent bakeries, however, may not have access to technical support in the addition of folic acid.  Folic acid fortification may present a particular challenge to artisan bakers who do not use premixed ingredients or emulsifiers.  These groups may require support from the baking industry associations in determining the best method of folic acid fortification for their bread products.

Analytical testing and other methods of verification may be required to confirm the consistent and correct levels of fortificant in the bread.  This may have cost implications for bread manufacturers, and is discussed in Section 11.2.2.

There are three, with two being owned by the same company, principal manufacturers of premixes for bakers in Australia and New Zealand, and at least one of these manufacturers have indicated the folic acid fortification of bread premix and bread improvers will not present any particular difficulty.

9.1.6 Domestic and export bread production

In Australia and New Zealand, bread is manufactured domestically to meet local market demands, and little bread is imported into either country.  Australian figures from 2001-02[36] show sales from exports of bread products account for less than one percent of turnover in bread manufacturing, however there is a growing export market for frozen doughs and par-baked products for both Australia and New Zealand.  The value of sales to meet Japanese Subway frozen dough exports has been estimated at NZ $12M per annum[37].  The addition of folic acid to bread at the bakery level has the advantage of flexibility for bakers in avoiding fortification of products for export.

9.1.7 Issues for speciality bakers and bread manufacturers

Mandatory folic acid fortification may be an issue for bakeries producing artisan breads using only ‘natural ingredients’, and for organic bread manufacturers.  Artisan bakers may consider the fortification of their products will not fit with their niche market, and could be seen as detrimental to sales.  Folic acid may not be considered a ‘natural ingredient’ as it is a synthetic form of folate, and may also conflict with organic industry standards.

Submitters from the organic production sector felt that mandatory folic acid fortification was incompatible with organic food production systems, which did not currently allow organic products to be fortified.  A number of submitters asked that organic bread and flour be exempt from mandatory folic acid fortification.  A few consumer and industry submitters also considered that folic acid would not be classified as a natural ingredient, and therefore breads could not be labelled as containing all ‘natural ingredients’.  This issue is discussed further at Section 13.3.2.

9.1.8 Labelling

All packaged bread will be required to list folic acid as an ingredient on the label of the bread.  Additionally, folic acid will be required to be listed if it is present as part of a compound ingredient[38] making up more than 5% of the final food.  

Labelling for the presence of folic acid will necessitate labelling modifications and as a result incur costs for manufacturers.  Labelling was raised as an issue in industry submissions, who noted the time and costs involved in making labelling changes.  Some industry submitters requested an extended transition time in order to change over packaging in a coordinated manner with other pending changes to the Code such as Proposal P230 - Consideration of Mandatory Fortification with Iodine, and Proposal P293 - Health, Nutrition and Related Claims.

9.1.9 Product liability and indemnity issues

9.1.9.1 Product Liability under VA of the Trade Practices Act 1974 (‘TPA’)

Industry submitters raised concerns about the potential product liability exposure for bread and/or flour manufacturers under Part VA of the Trade Practices Act 1974 (TPA).  For example one submitter has expressed concern as follows:

……that in relation to the possible health risks (especially in the longer term) FSANZ’s proposal may entail, FSANZ is applying a different risk management (i.e. safety) standard to that which industry proposals are required to satisfy.  When combined with the fact that FSANZ’s proposal will not deliver any protection to manufacturers from long term product liability claims, this is particularly worrying.

FSANZ has sought advice from the Australian Government Solicitor (AGS) on this issue and was advised that manufacturers are protected from liability where they have complied with a mandatory standard as defined in the TPA. 

It was further advised that where a standard is expressed as a minimum this is not considered to be a mandatory standard for the purposes of the TPA.  Currently the Code sets minimum standards for the mandatory fortification of bread-making flour with thiamin and edible oils with vitamin D.  FSANZ will be reviewing these standards in the future and will consider this issue at this time.

Alternatively, where a standard requires a range food X must contain between Y mg/kg and Z mg/kg of a vitamin, this may be a mandatory standard.  In relation to this example it would turn upon the evidence as to why a range, rather than an absolute value was not possible.  In the context of fortification, industry has indicated that the application of an absolute value is not achievable.  This is further supported by the US experience previously discussed (see section 9.1.4) where use of ‘overages’ routinely occurs.  The current drafting for folic acid requires bread to contain no less than 0.8 mg/kg and no more than 1.8 mg/kg of folic acid.  Consequently, it is arguable that prescribing a range would be considered a mandatory standard within the meaning of the TPA.  However, ultimately this would depend on how the Courts viewed the evidence submitted.

9.1.9.2 Other areas of potential liability

Industry also raised other areas of potential liability stating:

Even if we did have a defence in relation to an action under the product liability

provisions contained in Part VA of the TPA, or subordinate legislation were passed

by the Federal Government to deem a mandatory requirement under the Food

Standards Code to fortify bread-making flour with folate to be a Mandatory Standard

for the purposes of s75AA of the TPA, this would not prevent a successful action

against the manufacturer:

(i) under Division 2A of Part V of the TPA alleging that the goods were not of merchantable quality or fit for purpose; and/or

(ii) for negligence (on the basis that given what was known at the time, the risk of injury/harm to some members of the public was reasonably foreseeable).

Ultimately, whether an action is successful under Division 2A of Part V of the TPA and/or for negligence is a matter for the Courts.  FSANZ cannot pre-empt any Court decision and notes that certain legal elements would need to be proven.  This would be based on submissions made to the Court, together with, any evidence used to support those submissions.

9.1.9.3 Options to address liability issues

There has been a suggestion that FSANZ should seek agreement to have the TPA amended to deem the Code a ‘mandatory standard’ for the purposes of Part VA of the TPA.

To deem the Code a ‘mandatory standard’ under Part VA of the TPA would not be workable because not all standards in the Code contain ‘mandatory’ requirements.

Furthermore, the TPA is administered by the Department of Treasury and the Australian Consumer and Competition Commission (ACCC).  A decision to amend the TPA ultimately rests with those agencies. 

Also, any overarching government policy as it relates to these agencies would have to be considered as well as any possible inconsistency within the context of an agreement to amend the TPA.

9.1.9.4 Government to provide indemnity

Another two submitters requested that the Government issue an indemnity for incidences that may arise due to any adverse effects of folic acid fortification on consumers.  The Australian Government as a matter of policy does not issue indemnities.  In addition, the Australian Government does not issue indemnities to third parties dealing with statutory agencies covered under the Commonwealth Authorities and Companies Act 1997 (CAC Act).  FSANZ is a CAC Act body and as such, is not a Commonwealth body for legal and financial purposes.

9.2 Consistency with Ministerial Policy Guidance

The Ministerial Council’s Policy Guideline on Fortification of Food with Vitamins and Minerals (the Policy Guideline, see Attachment 3) provides guidance on the addition of vitamins and minerals to food for both mandatory and voluntary fortification.  In considering mandatory fortification as a possible regulatory measure, FSANZ must have regard to the Policy Guideline.

The Policy Guideline provides ‘High Order’ Policy Principles as well as ‘Specific Order’ Policy Principles and additional guidance for mandatory fortification.  The ‘High Order’ Policy Principles reflect FSANZ’s statutory objectives (see Section 4) and therefore take precedence over the ‘Specific Order’ Policy Principles. 

The five ‘Specific Order’ Policy Principles state that mandatory fortification should:

1. be only in response to demonstrated significant population health need taking into account the severity and prevalence of the health problem;
2. be assessed as the most effective public health strategy to address the public health problem;
3. be consistent with national nutrition policies and guidelines;
4. not result in detrimental dietary excesses or imbalances of vitamins and minerals; and
5. deliver effective amounts of added vitamins or minerals to the target group to meet the health objective.

Advice from the Ministerial Council is that mandatory folic acid fortification is an effective public health strategy to reduce the incidence of NTDs in Australia and New Zealand, subject to assessment of clinical safety and cost-effectiveness.  In recognition of this significant population health problem, FSANZ was asked to consider mandatory folic acid fortification.

However, a number of submitters asserted that mandatory folic acid fortification was inconsistent with the Specific Order Policy Principles.  Whilst acknowledging the severity of NTDs, they felt the low prevalence did not justify the population wide approach of mandatory fortification.  Other submitters stated that mandatory fortification was not the most effective public health strategy to prevent NTDs, and did not deliver sufficient folic acid to the target group, citing folic acid supplementation as a more effective means of NTD reduction. 

Some submitters were also concerned that mandatory fortification had potential for detrimental excessive intake of folic acid, and that this needed more consideration by FSANZ. 

As stated above, advice from the Ministerial Council is that mandatory fortification with folic acid is an effective strategy.  This advice was based on an Expert Panel convened by AHMAC[39] which reported that mandatory fortification fulfilled their criteria[40] of effectiveness, equity, efficiency, certainty, feasibility and sustainability required for an effective public health strategy.  They concluded that in considering strategies to increase folate intake mandatory fortification represents the most effective public health strategy where safety can be assured and there is a demonstrated need.  It is on this basis that FSANZ has undertaken this assessment which is consistent with recently revised Ministerial policy guidance (at Attachment 3) which states that:

The Australian Health Ministers Advisory Council, or with respect to a specific New Zealand health issue, an appropriate alternative body, be asked to provide advice to the Australia and New Zealand Food Regulation Ministerial Council with respect to Specific Order Policy Principles 1 and 2, prior to requesting that Food Standards Australia New Zealand raise a proposal to consider mandatory fortification.

9.2.1 Consistency with Australia and New Zealand national nutrition guidelines

Both the Australian and New Zealand dietary guidelines[41] for all age groups promote eating plenty of cereals including breads with particular emphasis on wholegrain varieties.  Therefore, the selection of a broad range of breads as the preferred food vehicle is consistent with, and supports, the current nutrition guidelines and healthy eating messages. 

9.2.2 Safety and effectiveness

On the available evidence assessed in this proposal, including overseas experience with mandatory fortification, FSANZ has concluded that the proposed level of fortification does not pose a risk to public health and safety.  The level of fortification has been set to minimise any potential health risks as a degree of uncertainty does exist, particularly for the non-target population, from increased folic acid intakes over the longer term.  FSANZ recognises that mandatory fortification is one strategy in NTD prevention, and that other strategies for reducing the incidence of NTDs will continue to be important.  These strategies include voluntary fortification, folic acid supplement use and education for women of child-bearing age

9.2.3 Additional Policy Guidance

The Policy Guideline provides additional policy guidance in relation to assessment of alternative strategies (see Section 2.5), labelling (see Section 13.3) and monitoring (see Section 17.1

9.3 Consumer issues

Mandatory fortification of bread with folic acid raises a number of important concerns from the perspective of consumers including:

• choice and availability of non-fortified products;
• awareness and understanding of folic acid fortification;
• impacts of mandatory fortification on consumption patterns; and
• labelling and product information as a basis for informed choice.

In understanding the impacts on, and responses of, consumers, FSANZ has drawn upon relevant consumer studies and literature regarding mandatory fortification, as well as more general literature review regarding the factors that influence health-related attitudes to food.

9.3.1 Choice and availability of non-fortified products

A range of socio-demographic variables influence health-related attitudes to food, for example age (Kearney et al., 1997; Worsley and Skrzypiec, 1998; Childs and Poryzees, 1998), gender (Worsley and Scott, 2000), income (Childs and Poryzees 1998), values (Ikeda, 2004) and personality (Cox and Anderson, 2004).  Accordingly the response to mandatory fortification of bread with folic acid is unlikely to be uniform, but rather will be mediated by the particular circumstances of individuals and the communities within which they live.  Attitudes and responses to mandatory fortification are also likely to vary within groups and over time.

The difficulty of assessing the likely responses of consumers to mandatory fortification is further exacerbated by a lack of specific studies exploring likely consumers’ responses.  Two recent studies of New Zealand consumers’ responses to mandatory fortification of bread with folic acid have been carried out: one commissioned by the Baking Industry Research Trust (Brown, 2004) and one by the New Zealand Food Safety Authority (Hawthorne, 2005).  No specific studies have been carried out in Australia.  Additionally a range of New Zealand and Australian studies measuring the effectiveness of folate promotion campaigns provide information about the level of folate awareness and understanding among women of child-bearing age (Abraham and Webb, 2001).  Currently the UK Food Standards Agency is undertaking consumer research to inform their assessment of mandatory folic acid fortification with the results expected to be available in September 2006 (UKFSA, 2006).

Consumer research has found varying levels of support for mandatory fortification.  The two New Zealand studies mentioned above both found the majority of participants were opposed to mandatory fortification with folic acid (Brown, 2004; Hawthorne, 2005).  This opposition was primarily based on strong support for individual rights rather than any specific concerns regarding folic acid fortification per se.  A third survey of New Zealand adults found that 58% of respondents considered choice to be very or extremely important to them, with 16% of respondents considering choice to be slightly or not important at all.  The survey also found that 49% of respondents neither agreed nor disagreed with the statement that ‘folate should be added to bread’ (Bourn and Newton, 2000).

Exposure to mandatory fortification is also likely to impact on the level of support for such measures.  In Canada, there was significant change between the public response to thiamin fortification in 1930s and 1940s and the response to folic acid fortification in the 1990s. 

The shift in response has been linked to a growing acceptance of fortification and of technological solutions (Nathoo et al., 2005).  Unlike Australia which mandates the fortification of bread-making flour with thiamin and fat spreads with vitamin D, New Zealand currently has no mandatory fortification requirements. 

The importance of consumer choice was raised by a large number of submitters, many of whom opposed mandatory fortification because consumers had little option but to purchase fortified bread products.  Some submitters did not feel that purchasing unfortified flour for bread-making provided sufficient consumer choice.  The fortification of bread, rather than bread-making flour will however provide a degree of further consumer choice in that flour products which do not meet the definition of bread will not be subject to mandatory fortification.

Some consumers may be opposed to mandatory folic acid fortification, and may wish to purchase unfortified bread.  Whilst all commercially manufactured bread will be required to be fortified with folic acid there will be some degree of consumer choice in that retail flours and bread-mixes will not be mandatorily fortified, and consumers will be able to purchase some non-fortified flat breads.  Additionally, through the use of labelling, consumers will be informed where products have added folic acid[42].

9.3.2 Awareness and understanding of folic acid fortification

Unlike some other nutrient disease relationships awareness and understanding of the link between folic acid and NTDs among the general community is low (National Institute of Nutrition, 1999; Abraham and Webb, 2001).  Not surprisingly though, women and men generally have different levels of awareness and understanding, with women generally being more informed of the rationale for ensuring adequate intake of folic acid.  Furthermore, the levels of awareness increases among women following public health campaigns targeted at pregnant women and women of child-bearing age (van der Pal-de Bruin KM et al., 2000; Abraham and Webb, 2001; Ward et al., 2004) although awareness does not necessarily lead to consumption of folic acid at the recommended time and dose (Watson et al., 2006b).  Women with some experience with NTDs among relatives are more likely to be aware and use folic acid supplementation (Byrne et al., 2001).

While there is likely to be a link between awareness and understanding and the level of support for mandatory fortification, the link may not be simple nor in expected directions (Wilson et al., 2004).  In one of the New Zealand studies, participants were provided with, and discussed, materials explaining the importance of folic acid in preventing NTDs (Hawthorne, 2005).  Despite this, opposition to mandatory fortification of bread with folic acid was high.  It is proposed to monitor the level of consumer awareness and understanding of folic acid fortification as part of the Bi-national monitoring system to track the impact of regulatory decisions on mandatory and voluntary fortification (Attachment 12).

9.3.3 Impacts of mandatory fortification on consumption patterns

The level of opposition to mandatory fortification raises a concern that consumers may change their consumption patterns to avoid fortified products. 

The limited evidence available suggests that this is unlikely, however, it is possible that some individuals may consume less of the fortified food categories (Brown, 2004).  A key element is the extent to which opposition is based on a notion of individual choice rather than other concerns such as health and safety.  As noted above there will be some limited options for those who wish to avoid the consumption of folic acid fortified products.

By contrast, some women may feel that, in addition to the availability of voluntary fortified products, the mandatory fortification of bread will provide enough folic acid.  This was a concern of a number of submitters, who noted that women of child-bearing age will still require supplementation to reach recommended levels of folic acid at the proposed level of folic acid in bread.  Submitters felt strongly that public health campaigns and advice from medical practitioners must continue to be important mechanisms to ensure women of child-bearing age take adequate supplementation.

There may be some groups of women who will not receive the health benefit of mandatory folic acid fortification as a consequence of not eating bread.  However there is little evidence that can be drawn upon to characterise these groups of women.  A number of submitters also commented that it was not clear whether only wheat flour, or bread made from wheat, was to be fortified.

The dietary intake data indicate that bread is widely and regularly consumed by the target group.  There is unlikely to be any substantial increase in the price of bread, and thus fortification will have insignificant financial impact. 

Women whose diets do not normally include bread will not consume the recommended amount of folic acid through mandatory fortification and will require additional supplementation.  This may include women who are intolerant to some cereals and therefore avoid wheat and other cereal flour based products.  However, all breads using yeast are expected to be folic acid fortified, and therefore commercially produced yeast risen bread made from cereal flours other than wheat will contain folic acid.  Women of ethnic and cultural groups who do not eat bread but other primary carbohydrate sources (e.g. rice) will also not receive the increase in folic acid through mandatory fortification.  Home bakers that use unfortified retail flour for their home bread baking may also not receive the advantage of folic acid fortification.  It will therefore be important that these groups are specific target audiences for the communication and education strategy on mandatory folic acid fortification (see section 17.3).

9.3.4  Labelling and product information as a basis for informed choice.

Consumers will be informed about the addition of folic acid to bread through general labelling requirements that require all ingredients of a product to be identified in the ingredient list (see Section 13.3).  Additionally, if manufacturers choose to do so, or where a claim is made about a product and its folate content (naturally-occurring and added folic acid), folate will be declared in the Nutrition Information Panel.  This information will enable consumers to choose products according to their preference. 

Whilst all packaged bread will be required to list folic acid in the ingredient list, unpackaged bread is currently exempted from this requirement.  In these instances, consumers can request information about the presence of specific ingredients in these foods.  FSANZ will seek the assistance of retail bakeries in making this information available.

9.4 Factors affecting safe and optimal intake

The Risk Assessment raises a number of uncertainties with fortification associated with ensuring the sustainability and predictability of folic acid intake across the population.

9.4.1 Mandatory fortification

The amount of folic acid that can be delivered to the target population from mandatory fortification is dependent on:

• the consumption of the food vehicle;
• the level of fortification; and
• safety considerations for both the target and non target populations. 

The food vehicle and fortification level have been selected to maximise folic acid intakes in the target group, while also preventing significant proportions of the non-target population exceeding upper safe levels of intake.  This consideration is particularly relevant when the recommended intake for the target population differs markedly from the non-target group, as is the case for folic acid.  The recommendation for the target population is 400 µg of folic acid, whereas for children aged 1-3 years the RDI expressed as DFEs is 150 µg per day. 

Mandatory fortification can deliver additional amounts of folic acid in the food supply for women of child-bearing age.  However, the amount delivered for women of child-bearing age does not by itself reach recommended levels.  Thus, additional strategies will be needed to assist the target group to achieve the recommended folic acid intake to reduce the NTD risk as much as possible.

The method of adding folic acid to bread will affect the accuracy of fortification, though both the addition of an improver or a premix containing folic acid during dough mixing are considered to be a more precise and flexible means of fortifying bread[43]. 

The current industry practice of ‘overages’ to account for losses of folic acid on processing, baking and storage is an additional concern with mandatory fortification.  The practice of ‘overages’ when used under a mandatory fortification scenario may result in an increase in folic acid intake greater than anticipated.  For example, in the United States, mandatorily fortified foods have been found to contain nearly twice as much as their predicted levels (See Attachment 4).  As there is a potential risk for some population groups to exceed the UL of intake for folic acid, this risk will need to be managed when setting the level of fortification. 

9.4.2 Voluntary fortification

Folic acid intake from current voluntary fortification permissions formed the baseline for the dietary modelling scenarios.  In general, there has been limited uptake of voluntary permissions across the food categories, with the exception of breakfast cereals.

It is uncertain how the use of voluntary folic acid fortification permissions might change following the implementation of mandatory fortification. 

There is potential for the implementation of mandatory fortification to increase consumer awareness of the relationship between folic acid and NTDs, creating more marketing opportunities for other food categories to be voluntarily fortified.  As a result, more voluntary folic acid permissions may be utilised.  Alternatively, mandatory fortification may result in loss of marketing advantage for products currently voluntarily fortified, resulting in less folic acid permissions being used.  If uptakes do change significantly, this may impact on the effectiveness or safety of mandatory folic acid fortification.

The mandatory fortification scenario assumes that folic acid will be added to bread as defined in the Code, and not to other bread products such as pizza dough and some flat breads that do not meet this definition.  However, current voluntary permissions allow cereal flours to be fortified with folic acid.  This presents a situation where bread products that do not meet the definition of ‘bread’ in the Code may also be fortified with folic acid.  These voluntary permissions also present the opportunity for food manufacturers to use folic acid fortified cereal flours in the production of foods that are consumed by subsets of the target population who do not eat traditional bread products.  If this occurs, manufacturers will be required to comply with the labelling requirements of the Code and will need to include folic acid in the ingredient list.

9.4.3 Folic acid supplement use

Folic acid intake from mandatory fortification combined with folic acid intake contributed by foods voluntarily fortified with folic acid, is less than the 400 g folic acid recommended for women of child-bearing years.  Folic acid supplementation for women planning to, or capable of, becoming pregnant will therefore continue to be an important strategy in NTD prevention.

The dietary intake assessment demonstrated that when folic acid supplements of 500 µg (in Australia)[44] and 800 µg (in New Zealand) are taken daily by women of child-bearing age in addition to fortified foods, the mean intakes of folic acid increase substantially.  This is of particular relevance for women who consume the 800 µg supplement, as it may result in some of these women exceeding the UL.  As supplementation at this level is generally confined to the peri-conceptional period, long term exposure to this level of folic acid is unlikely. 

However, it is uncertain if some women of child-bearing age will falsely believe that mandatory fortification of foods with folic acid delivers sufficient folic acid for NTD prevention, and therefore folic acid supplementation during the peri-conceptional period is not necessary.

The level of use by children of supplements containing folic acid is unclear.  Estimated folic acid intake for children shows that if mandatory fortification is introduced a proportion of children are likely to exceed the UL (see Section 7.2.2.1).  Therefore, if a child is given additional folic acid in the form of supplements, the likelihood of this child being exposed to folic acid at levels exceeding the UL would be raised.  While there have been no reported health risks associated with increased folic acid intake from international experience, a conservative approach has been recommended due to the uncertainties about health risks, particularly for young children.

9.5 Summary

A number of risks and issues affecting consumers and industry arising from mandatory folic acid fortification of bread have been identified.  These are:

• factors contributing to a degree of uncertainty about the folic acid intake of the target group and the general population, notably uptake of voluntary permissions by industry, the possibility of overages in folic acid fortification, and future folic acid supplement use in women of child-bearing age, and the general population;
• the impact of mandatory fortification on consumer choice and provision of information to consumers to enable identification of fortified products; and
• the impact on the baking industry who will have to develop quality control systems for the addition of folic acid, and the impact on enforcement agencies who will have to develop manageable systems for establishing compliance in the baking industry.

Strategies for the management of these identified risks and issues as they relate to the preferred regulatory option are addressed later in this Report (see Section 13).

10. Regulatory options

Selection of bread as the food vehicle chosen for fortification is on the basis of its ability to effectively deliver and sustain an increase in the folic acid intake of the target population.  Consequently at Final Assessment the following two options have been identified.

10.1 Option 1 – Current approach – the status quo

Maintenance of the status quo would see the continuation of the existing permissions for the voluntary addition of folic acid to certain foods as well as the continuation of the folate-NTD health claim.  In recent years there has been limited uptake of voluntary permissions across food categories, with the exception of breakfast cereals.  Currently, there are very few products using a folate-NTD health claim.

Australia and New Zealand have health promotion and education strategies in place to promote the use of folic acid supplements and increase folate intakes in women of childbearing age.  These strategies would be expected to continue under the status quo.

10.2 Option 2 – Mandatory folic acid fortification of bread products

This Option requires all bread[45] to be fortified between 80-180 µg (on average 135 µg) of folic acid per 100 g of bread, a concentration that will reduce the rate of NTDs in Australia and New Zealand.  Industry will be able to choose how to comply with this requirement.   The options for industry include:

(a) adding folic acid to flour used in bread-making; or

(b) adding folic acid at a later stage of bread production, such as to the pre-mix, via improvers or to a vitamin pre-mix.

Australia and New Zealand have health promotion and education strategies in place to promote the use of folic acid supplements and increase folate intakes in women of child-bearing age.  These strategies would be expected to continue under this Option.

Under a mandatory fortification option, monitoring is necessary and would be an important part of the implementation of the proposed Standard.  FSANZ believes that it is important to undertake an assessment of the incidence of NTDs in both Australia and New Zealand at the commencement of this Standard to provide a benchmark for future monitoring as well as other features bearing on the success of the Standard after gazettal.  In addition, monitoring for the uncertainties is an important risk management aspect of this Option.  Monitoring is discussed in more detail later in this Report. (see Section 18.1).

The responsibility for establishing and funding a monitoring system to assess the impact of mandatory fortification on the population extends beyond FSANZ’s responsibilities under the FSANZ Act and will require the concomitant involvement of health and regulatory agencies at the Commonwealth, State and Territory level in Australia and the New Zealand Government.

11. Impact Analysis

11.1 Affected parties

The parties most likely to be affected by this Proposal are:

11.1.1 Industry

• Bakers and flour millers.
• Industry involved in bread production including pre mixing and baking.
• Specialist producers – e.g. organic, gluten free etc.

11.1.2 Consumers

• Women of child-bearing age i.e. target consumers.
• Other non-target consumers of bread.

11.1.3 Government

• Food standards enforcement agencies of New Zealand and Australian State and Territory Governments.
• Australian, State and Territories and the New Zealand Governments.

11.2 Cost-benefit analysis of regulatory options

FSANZ commissioned Access Economics in March 2006 to investigate the benefits and costs of fortifying bread-making flour in Australia and New Zealand with folic acid.  A further cost analysis undertaken by Access Economics in August 2006, looked at the cost differences between the original proposal of fortifying bread-making flour, and allowing the fortification of bread during later stages of the production process.

A number of countries (for example, the United States and Canada) have adopted mandatory fortification but few cost-benefit analyses have been undertaken.  However, an analysis of fortification with folic acid of enriched cereal products in the United States suggested that such a policy is associated with net benefits (Grosse et al., 2005, see Attachment 11).  This is consistent with the results of the first Access Economics study.

The following information is based on the two Cost-Benefit Analyses prepared by Access Economics, which are provided in full at Attachments 11a and 11b.

11.2.1 Methodology

The analysis of benefits focused on the costs avoided as a result of new cases of NTDs per year that could be prevented in future.  The costs avoided through a fall in the occurrence of NTDs include pain and suffering from disability and premature mortality, total outlays on health care and personal care, productivity losses, and efficiency losses that arise from lower taxation revenues and higher welfare payments.

The costs of mandatory fortification include the costs to government of administering, enforcing mandatory fortification and the costs to industry of fortifying their product.  The costs to consumers of reduced choice have been identified in-principle but were not able to be quantified.  The costs also include monitoring mandatory fortification, which were not included in the original Cost-Benefit Analysis have been included in the second analysis prepared by Access Economics.

11.2.2 The benefits

The benefits of the Proposal follow from fortification of folic acid in the final bread product.  In the previous report a suitable concentration of folic acid in the final bread could be delivered by fortifying bread-making flour.  In this report the option has been broadened to allow choice of how to fortify bread products with folic acid; industry may choose bread-making flour as the vehicle or industry may choose to add folic acid in later stages of the bread making process.

In each case the concentration in the final bread will be the same at an average of 135µg of folic acid per 100 grams of bread.  Hence benefits of the Proposal remain as described in the previous report.

New cases of NTDs prevented through mandatory fortification were estimated by FSANZ (see Section 7.1).  Three scenarios were modelled: lower estimates of NTDs prevented, mean estimates and upper estimates of NTDs prevented.  The projected mean number of incident cases prevented per year is presented in Table 7 below.

Benefits were calculated based on two scenarios:

• live NTD births prevented (i.e. excluding terminations and still births prevented by fortification on the basis of ‘replacement’ births); and
• all NTD births prevented (i.e. including NTD terminations and still births prevented by fortification on the basis of the intrinsic value of human life).

Table 7:  Projected number of neural tube defect incident cases prevented per year

Source: FSANZ modelling

The benefits for Australia and New Zealand include:

• the pain and suffering from disability and premature mortality avoided through fortification (disability adjusted life years (DALYs) avoided).  The value of these in dollars is the net burden of disease;
• production losses avoided through prevention of NTDs (the loss of lifetime earnings of people with NTDs who are not able to participate fully in the labour force, and of NTD pregnancies terminated or NTD still births who may otherwise have survived and accrued lifetime earnings);
• avoided outlays on health care and personal care (‘other costs’ in the table) — based on live NTD births prevented; and
• avoided efficiency losses that arise from lower taxation revenues and higher welfare payments as a result of the occurrence of NTDs.

The benefits of avoiding disability and premature death (net burden of disease) form the largest component of the benefits of mandatory fortification, followed by productivity losses.

Table 8:  Summary of benefits of mandatory fortification for Australia and New Zealand

11.2.3 The costs

As a result of mandatory fortification, consumers will face reduced choice and potentially a slight increase in the price of bread.  This increase is likely to be small, perhaps up to 2% per loaf.  The price increase would occur because under mandatory regulatory measures all affected businesses typically pass on all or most costs that are incurred at some stage.  The cost of reduced choice was not able to be quantified. 

The costs to industry of mandatory fortification of all bread with folic acid are different under the two alternative methods for adding folic acid considered by Access Economics.  These methods are adding folic acid to bread-making flour, and adding it during a later stage of bread production.  Table 9 below sets out the costs under each alternative for industry and government in both Australia and New Zealand.

In the first year, industry in both Australia and New Zealand would incur costs associated with both changing labelling and packaging as well as costs related to the purchase of folic acid, preparation of premix, the per annum costs associated with additional machinery and equipment, analytical testing, flushing out mills, storage and administration.  Industry advised very high costs of writing off existing stocks of labels, even with a twelve month transition period, that have been included in this analysis.

FSANZ has estimated the cost of equipment purchases under the fortification of flour option to be A$264,000.  For the purposes of this calculation it was assumed that a folic acid feeder would be purchased by each of the eight largest Australian millers at a cost of A$33,000 per feeder.  This was based on independent United States figures.  The cost for the bread production fortification option, was estimated by Access Economics on the basis of information by New Zealand industry, at NZ$1,202,000.

We have assumed a cost of equipment in New Zealand under the fortification of bread option, using this same independent United States data, of NZ$80,000.  An estimate has then also been included to cost the fact that other smaller producers may purchase equipment at lower cost.  The upfront equipment cost for fortification of flour in New Zealand was calculated by Access Economics as NZ$1,470,000.

The once off (first year) costs of changes to labelling pre-packaged products are likely to affect a large number of product lines because labelling standards require that the ingredients of a compound (such as bread-making flour) be declared if the amount of the compound ingredient in the final food is 5 per cent or more by weight. 

The cost in the first year for industry under the fortification of bread flour option, is estimated at A$6,586,400 for Australia and NZ$2,385,620 for New Zealand.  The upfront costs under the fortification of bread during the production stage, are less, at A$5,738,400 and NZ$996,063 for Australia and New Zealand respectively.

The upfront government costs, which include administration, enforcement and monitoring, are the same whether folic acid is added to flour or during bread production.  The costs are estimated at A$1,273,000 for Australia and NZ$60,920 for New Zealand.

The ongoing costs for industry include the cost of maintenance of equipment, folic acid and premix, analytical testing to ensure compliance, administration and cleaning of mill.  The cost figures for fortifying flour compared with fortifying bread during production vary considerably in some cases.  Under the fortification of bread-making flour option the total ongoing industry costs per year for Australia are A$1,058,592, compared to A$24,486,067 for the fortification of bread option.  In New Zealand these costs are NZ$2,377,738 for fortifying bread-making flour and NZ$4,149,593 for fortifying during bread production.

Access Economics took a conservative approach to calculating industry costs by accepting information provided by industry.  These costs may be at the high end of a plausible range.  FSANZ considers that the actual costs incurred by industry may be somewhat lower then the cost estimates in Table 9.

Access Economics’ estimates for the annual costs of government administration and enforcement of mandatory fortification in both Australia and New Zealand include the costs of awareness raising and training, compliance auditing, administration and enforcement (dealing with complaints).  These ongoing, annual costs for government are assumed to be the same whether fortification occurs at in bread-making flour, or during the production of bread.  Ongoing administration and enforcement costs for Australia are A$2,210,000 and NZ$88,500 for New Zealand.  Monitoring costs have been listed separately and are higher for the second year following introduction of the mandatory fortification proposal.  These costs are A$455,000 for Australia in the second year and NZ$485,000 for New Zealand.  For all years after the second year, monitoring costs are A$355,000 for Australia and NZ$378,000 for New Zealand.

Table 9:  Summary of costs of mandatory fortification