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ImplementationFollowing 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 iii Consultation v 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
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
2.1.1 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
5.1.1 Experience in other countries following mandatory fortification 23 5.1.2 Comparative rates for Australia and New Zealand 24
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
6.9.1 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
7.2.1 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
9.4.1 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
69 13.1.1 Level of fortification 69 13.1.2 Impact of voluntary fortification 70 13.1.3 Folic acid supplement use 71
13.3.1 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
1.1 Maintaining the status quo 88 1.2 Mandatory folate fortification 89
7.1 Dietary modelling 94 7.2 Modelling of NTDs prevented 94
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
1.1 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
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
separate Attachments: 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 Yüklə 2,26 Mb. Dostları ilə paylaş:
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