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.
Executive Summary iii
Consultation v
Key issues vi
Will mandatory fortification of bread with folic acid result in other health benefits? vi
Are there any possible health risks from mandatory fortification with folic acid? vi
Does mandatory fortification allow for consumer choice? vii
How will industry implement mandatory folic acid fortification? vii
How will mandatory fortification be monitored? vii
What other strategies are planned to support mandatory fortification? viii
Implementation viii
Introduction 7
Scope of this Proposal 8
1. Background 9
1.1 Folate terminology and forms 9
1.2 Nutritional role of folate 9
1.3 Neural Tube Defects (NTDs) 11
1.4 Regulation of folic acid in foods in Australia and New Zealand. 12
1.5 Existing mandatory fortification requirements 12
1.6 International regulation of folic acid in foods 13
1.6.1 Codex Alimentarius 13
1.6.2 Countries with mandatory folic acid fortification 13
Sources: 14
2. Current approaches to increasing folate intake 15
2.1 Folic acid supplement recommendations and availability 15
2.1.1 Australia 15
2.1.2 New Zealand 16
2.1.3 Online sales 16
2.2 Folic acid supplement use among women of child-bearing age 16
2.3 Promotion of folate-rich foods and folic acid supplements 17
2.4 Voluntary fortification of foods with folic acid 17
2.4.1 Current estimates of folic acid intake from voluntary fortification 17
2.4.2 Estimated improvement in folate status from voluntary folic acid fortification 18
2.4.3 Estimated reduction in neural tube defects from voluntary folic acid fortification 18
2.5 Summary of the current approach to increasing folate intake 19
3. The Health Issue 19
4. Objectives 20
RISK ASSESSMENT of mandatory fortification 22
5. What are the potential health benefits, particularly regarding rates of NTDs, and potential health risks from increases in folic acid intake? 23
5.1 Neural tube defects 23
5.1.1 Experience in other countries following mandatory fortification 23
5.1.2 Comparative rates for Australia and New Zealand 24
5.2 Masking of the diagnosis of vitamin B12 deficiency 25
5.2.1 Effects of exceeding the upper level of intake (UL) for individuals who are not vitamin B12 deficient 26
5.3 Cardiovascular disease 27
5.4 Cancer 27
5.4.1 Total cancer 27
5.4.2 Prostate cancer 27
5.4.3 Breast cancer 28
5.4.4 Colorectal cancer 28
5.4.5 Conclusion 28
5.5 Cognitive function 28
5.6 Unmetabolised circulating folic acid 29
5.7 Other effects during pregnancy 29
5.8 Other potential health risks 29
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? 29
6.1 Selection of food vehicle 30
6.1.1 The suitability of bread as the selected vehicle 32
6.1.2 Stability of folic acid added to bread 33
6.1.3 Bioavailability of folic acid 33
6.2 Dietary targets 34
6.3 Fortification scenarios 34
6.4 Assessment of baseline folic acid intakes 35
6.5 Selection of folic acid concentrations 35
6.7 Dietary intake assessment for women of child-bearing age 35
6.7.1 Estimated folic acid intake from fortified foods 35
6.7.2 Estimated folic acid intake from fortified foods and supplements 36
6.8 Robustness of the estimates used to determine bread consumption and folic acid intakes 37
6.9 Alternative approaches to mandatory fortification 38
6.9.1 Restricting breads that are mandatorily fortified in response to concerns about consumer choice 38
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 38
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 39
7. Based on the expected increase in folic acid intake from mandatory fortification what are the likely health benefits and risks? 39
7.1 Expected reduction in neural tube defects 39
7.2 Health risks to the whole population 41
7.2.1 Comparison of estimated dietary folic acid intakes with the UL 41
Table 6: Per cent of Australian and New Zealand respondents with folic acid intakes above the UL at Baseline and Scenario 1 42
7.2.2 Masking of the diagnosis of vitamin B12 deficiency 42
7.2.3 Uncertainties 43
8. Risk assessment summary 44
risk management of mandatory fortification 45
9. Identification of risk management issues 45
9.1 Technical and industry issues for mandatory fortification 45
9.1.1 Bread production in Australia and New Zealand 45
9.1.2 Bread and bread products 47
9.1.3 Bread fortification methods 47
9.1.4 Range of addition 48
9.1.5 Baking industry capacity for mandatory folic acid fortification 48
9.1.6 Domestic and export bread production 48
9.1.7 Issues for speciality bakers and bread manufacturers 49
9.1.8 Labelling 49
9.1.9 Product liability and indemnity issues 49
9.2 Consistency with Ministerial Policy Guidance 51
9.2.1 Consistency with Australia and New Zealand national nutrition guidelines 52
9.2.2 Safety and effectiveness 52
9.2.3 Additional Policy Guidance 52
9.3 Consumer issues 53
9.3.1 Choice and availability of non-fortified products 53
9.3.2 Awareness and understanding of folic acid fortification 54
9.3.3 Impacts of mandatory fortification on consumption patterns 54
9.3.4 Labelling and product information as a basis for informed choice. 55
9.4 Factors affecting safe and optimal intake 56
9.4.1 Mandatory fortification 56
9.4.2 Voluntary fortification 56
9.4.3 Folic acid supplement use 57
9.5 Summary 58
10. Regulatory options 58
10.1 Option 1 – Current approach – the status quo 58
10.2 Option 2 – Mandatory folic acid fortification of bread products 58
11. Impact Analysis 59
11.1 Affected parties 59
11.1.1 Industry 59
11.1.2 Consumers 59
11.1.3 Government 59
11.2 Cost-benefit analysis of regulatory options 59
11.2.1 Methodology 60
11.2.2 The benefits 60
Table 7: Projected number of neural tube defect incident cases prevented per year 61
Table 8: Summary of benefits of mandatory fortification for Australia and New Zealand 61
11.2.3 The costs 62
Table 9: Summary of costs of mandatory fortification 64
11.2.4 Net benefits 65
Table 10: Net benefits live NTD births 65
Table 11: Net benefits all NTDs 66
11.2.5 Key findings 67
12. Comparison of Options 67
13. Strategies to manage risks associated with mandatory fortification 69
13.1 Managing safety and effectiveness 69
69
13.1.1 Level of fortification 69
13.1.2 Impact of voluntary fortification 70
13.1.3 Folic acid supplement use 71
13.2 Consumer Choice 71
13.3 Labelling and information provision 72
13.3.1 Use of nutrition and health claims 73
13.3.2 ‘Natural foods’ and related descriptor labels 74
Communication and consultation 74
14. Communication and Education Strategy 74
15. Consultation 74
15.1 Initial Assessment 74
15.2 Draft Assessment 75
15.3 Targeted consultation process 75
15.4 Outcomes from targeted consultations 76
15.5 World Trade Organization 77
CONCLUSION 77
16. Conclusion and the decision 77
17. Implementation and Review 79
17.1 Transitional Period 79
17.2 Regulatory compliance issues 80
17.3 Communication and education strategy for the preferred regulatory option 80
18. Monitoring 81
18.1 Monitoring and review of the impact of mandatory folic acid fortification 81
18.2 Comments on monitoring in submissions 83
References 85
Attachment 1 86
Draft variation to the Australia New Zealand Food Standards Code 86
Attachment 2 88
Summary of Submissions from the Draft Assessment Report 88
Executive Summary 88
Background 88
1. Regulatory options 88
1.1 Maintaining the status quo 88
1.2 Mandatory folate fortification 89
2. Choice of food vehicle for fortification 91
3. Potential benefits and risks of increased folate status 91
4. Level of fortification 91
5. Impact of fortification on consumer choice 92
6. Impact of fortification on industry 92
7. Data issues 94
7.1 Dietary modelling 94
7.2 Modelling of NTDs prevented 94
8. Alternative strategies to increase folic acid intakes 94
9. Folic acid supplements 96
10. Cost benefit analysis (CBA) 96
11. Monitoring 96
12. Education and communication strategies 96
13. Enforcement and compliance 97
14. Implementation and transition period 97
15. Consistency with Ministerial Council Policy Guideline on Fortification of Food with Vitamins and Minerals 97
Modified Option 2 111
Alternative proposal to include: 111
Alternative Industry Proposal 120
Consultation 120
International Experience 123
Codex Alimentarius 123
Supplements 124
Voluntary fortification 124
Health risks 125
Industry and technical issues 126
Consumer choice 127
Communication and education strategy 128
Monitoring 128
Proposal objective 129
inconclusive evidence of other health benefits from increased 129
folic acid intakes. 129
Supports a modified Option 2 149
Alternative proposal is provided. 149
Concerns with current proposal 149
Impact on Industry 150
Export risk 150
Consumer choice 151
Cost benefit analysis 151
Other concerns include: 151
Alternative proposal 151
fortifying a significant proportion of a range of breads (e.g. light grain breads) identified by consumer research as most popular with the target group. NZAB will assist with funding of this research; 151
Consider benefits of the alternative proposal include: 152
Disadvantages of alternative proposal include: 152
Differentiating between Australia and New Zealand 156
Data 156
Cost benefit analysis 156
Is considered inadequate because it does not include: 156
Supports option 2 191
Supports mandatory fortification as a means of delivering equity 191
Consumer choice 202
Education 203
Labelling 203
Voluntary permissions 203
Monitoring and evaluation 203
Supports a modified Option 2 204
Consumer Choice 205
Health risks 205
Labelling 205
Impact on industry 206
Dietary modelling 206
Trade issues 207
Monitoring 207
Key issues in developing a monitoring programme for folic acid: 207
NTD monitoring 208
Enforcement 208
Education 209
Communication strategy 209
Organics and natural 209
International experience 209
Supplements 210
Form of folic acid 210
Alternative proposal 210
Note that their alternative proposal does not identify the specific range of bread products to be fortified. NZFSA to provide further information on this in the near future. 211
Safety and effectiveness 211
Food vehicle 211
Supplements 211
Results from the most recent NSW Health Survey indicate that 32.8% of the mothers of young children took folate supplements in the peri-conceptual period, a similar figure to that found in Western Australia after an intensive education campaign. 211
Impact on industry 212
Cost benefit analysis 212
Health claims 212
Health risks 213
Education 213
Cost benefit analysis 213
Food vehicle 213
Data 213
Voluntary fortification 214
Monitoring 214
Consumer choice 214
Attachment 3 216
Policy Guideline 216
Within the context of this policy ‘Fortification’ is to be taken to mean all additions of vitamins and minerals to food including for reasons of equivalence or restoration. 216
This Policy Guideline provides guidance on development of permissions for the addition of vitamins and minerals to food. 216
‘High Order’ Policy Principles 216
Specific Order Policy Principles - Mandatory Fortification 217
Additional Policy Guidance - Mandatory Fortification 217
Specific order policy principles – Voluntary fortification 218
Additional Policy Guidance - Voluntary Fortification 219
Attachment 4 220
Impact of mandatory fortification in the United States of America 220
Attachment 5 224
Current approach to increasing folate intake among women of child-bearing age 224
References 231
Attachment 6 232
Potential health benefits and risks of increased folic acid intake 232
1. Reduction in the incidence of neural tube defects 232
1.1 Experience in other countries following mandatory fortification 232
2. Masking the diagnosis of vitamin B12 deficiency 234
2.1 Prevalence of vitamin B12 deficiency in Australia and New Zealand 235
2.2 International experience with folic acid fortification and vitamin B12 deficiency 237
3. Cardiovascular disease 238
4. Cancer 239
4.1 Total cancer 240
4.2 Prostate cancer 240
4.2 Breast cancer 242
4.3 Colorectal Cancer 245
4.4 Overall conclusion 247
5. Cognitive function 247
6. Unmetabolised circulating folic acid 248
7. Other effects during pregnancy 249
7.1 Multiple births 249
7.2 Birth weight 249
7.3 Down syndrome 249
8. Folate-drug interactions 250
8.1 Anti-epileptic drugs 250
8.2 Anti-folate drugs 250
8.3 Anti-inflammatory drugs 251
9. Interactions with zinc status 251
10. Impact on the gene pool 251
11. Summary of the benefits and risks associated with increased folic acid intake 251
11.1 Potential health benefits 251
11.2 Potential health risks 252
11.3 Areas of uncertainty in the scientific literature 252
References 253
GLOSSARY 254
Abbreviations and Acronyms 256
Attachment 12 – development of a bi-national monitoring system to track the impact of regulatory decisions on mandatory and voluntary fortification