Dear Stakeholder
Fortification of the Food Supply with Vitamins and Minerals: Consultation Paper on Draft Policy Guidelines
The attached consultation paper has been prepared by the Food Regulation Standing Committee (FRSC) as part of the process of developing policy guidance. Your comments are invited on the issues raised in the paper.
Fortification of the food supply with vitamins and minerals is permitted under the joint Australia New Zealand Food Standards Code. Standard 1.3.2 Vitamins and Minerals sets out the provisions for voluntary fortification whereas mandatory fortification requirements are contained in the relevant standards for cereals and cereal flours; edible oil spreads; and salt and salt products. The key factors underlying the need for a policy review of fortification include an increase in the number of industry applications to Food Standards Australia New Zealand (FSANZ) to voluntarily fortify foods; requests to the Ministerial Council to consider mandatory fortification to address significant public health issues; and advances in nutrition science and improvements in our understanding of health and nutrition.
The consultation paper recognises the inter-relationships between the food type dietary supplements, novel foods and nutrition and health claims policy development processes. These three policy areas have already been subject to public consultation and while novel foods and health claims policies are nearing completion, it is intended that the policy on food type dietary supplements will now develop in parallel to the policy on fortification. Policy development on food type dietary supplements, however, will need to consider additional issues relating to the foods/medicines interface.
The Food Regulation Standing Committee has developed the Consultation paper to seek community views on options for the regulation of the fortification of food. The question to be considered with respect to mandatory fortification is whether to continue to permit mandatory fortification or not, and if so, under what conditions. Three options are also presented for voluntary fortification (ie fortification that is permitted by government but is used at the discretion of industry). It is likely that a policy guideline covering mandatory fortification will proceed in advance of policy on voluntary fortification because of the broader range of issues to be addressed in considering voluntary fortification.
Your comments on the issues outlined will enable FRSC to provide advice to Ministers, as part of their decision making process.
Submissions on the attached consultation paper are sought by 5 February 2004. Information on the submission process is covered in the introduction of the paper.
(Authorised for the purpose of electronic transmission)
Jane Halton
Chair, Food Regulation Standing Committee
1 December 2003
Fortification of the Food Supply with Vitamins and Minerals: Consultation Paper on Draft Policy Guidelines
Produced for the Food Regulation Standing Committee By the Working Group on Fortification
December 2003
TABLE OF CONTENTS
Introduction 3
Technical Definitions 4
Purpose 5
Scope of Draft Fortification Policy Guidelines 5
Context. 5
Domestic Setting 6
International Setting 6
Mandatory and Voluntary Fortification 6
The Rationale for Fortification 6
Who decides what will be Fortified 7
Key Issues for Both Mandatory and Voluntary Fortification 7
Public Health Safety 7
Well Balanced Diet and Nutrition Policies 7
Food Vehicles 8
Bioavailability of the Particular Fortificant 8
Labelling & Claims 8
Implications for Food Type Dietary Supplements 9
Consumer Impacts 9
Industry Impacts 10
Government Impacts 11
Draft Policy for Mandatory and Voluntary Fortification 12
Scope & Aim 12
Proposed High Order Policy Principles 12
Mandatory Fortification – Proposed Specific Policy Principles 13
Mandatory Fortification – Proposed Policy Position 13
Decision making for Mandatory Fortification 13
Voluntary Fortification – Proposed Specific Policy Principles 14
Policy Options for voluntary fortification 14
Questions for Consideration 16
APPENDIX A: Codex Alimentarius General Principles for the Addition of Essential Nutrients to Foods 17
Definitions 17
APPENDIX B: FSANZ Development of Standards Regulating Vitamins and Minerals 20
APPENDIX C: International Setting 22
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INTRODUCTION
The Food Regulation Standing Committee is seeking comments from all interested persons on the draft policy guidelines on Fortification developed by the Food Regulation Standing Committee's Working Group on Fortification and a sub-group of the Food Regulation Standing Committee.
The Food Regulation Standing Committee is responsible for co-ordinating policy advice to the Australia New Zealand Food Regulation Ministerial Council (Ministerial Council) and advises the Ministerial Council on the initiation, review and development of Standing Committee activities.
The Food Regulation Standing Committee has developed this document to seek community views on the proposed approach on Fortification. Following the consultation period, the revised policy guidelines and a summary of submissions will be recommended to the Ministerial Council. If approved by the Ministerial Council, the Policy Guidelines will be provided to Food Standards Australia New Zealand to form the framework within which the food standards will be developed.
The consultation documents are available for download from the Food Regulation Website (www.foodsecretariat.health.gov.au). If you are unable to access the Internet please contact the Food Regulation Secretariat on (02) 6289 5128 or fax to (02) 6289 5100 or in
New Zealand, the New Zealand Food Safety Authority on (04) 463 2628 or fax to (04) 463 2583.
All submissions are subject to the Freedom of Information Act 1982 in Australia and the Official Information Act 1982 in New Zealand. If you consider that all or part of your submission should not be released, please make this clear when making your submission and indicate the grounds for withholding the information.
A summary of submissions will be produced and published on the Food Regulation Secretariat website at www.foodsecretariat.health.gov.au and the New Zealand Food Safety Authority website at www.nzfsa.govt.nz. Copyright will continue to reside in the author/s of a submission. Electronic submissions to the e-mail addresses below are preferred.
It would be appreciated if submitters could address the list of questions on page 16, by COB 5 February 2004 to:
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Australia
Submissions – Fortification
C/- Secretariat PO Box 4
WODEN ACT 2606
Or email to: Or fax to: (02) 6289 5100
New Zealand
Submissions – Fortification
C/- Policy and Regulatory Standards Group (Composition and Labelling)
New Zealand Food Safety Authority (NZFSA) PO Box 2835
WELLINGTON
Or email to: Or fax to: (04) 463 2583
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TECHNICAL DEFINITIONS
The technical definitions used in this document are based on definitions used by the Codex Alimentarius or contained in the Australia New Zealand Food Standards Code (the Code) or related documents.
Claimable food means those foods that are permitted to make a vitamin or mineral content claim.
Content Claim means a content claim may be made in relation to the presence of a vitamin or mineral in a food if (a) the claim is specifically permitted elsewhere in the Code; or (b) (1) the vitamin or mineral is listed in column 1 of the Schedule to Standard 1.1.1; and (2) the food is a claimable food; and (3) a reference quantity of the food contains at least 10 percent of the Recommended Dietary Intake or the Estimated Safe and Adequate Daily Dietary Intake, for that vitamin or mineral.
Demonstrated Need means that there is evidence of inadequate intake or sub-optimal nutritional status for the population or target group.
Essential Nutrient means any substance normally consumed as a constituent of food which is needed for growth and development and the maintenance of healthy life and which cannot be produced in adequate amounts by the body.
Food Type Dietary Supplements refers to food that is of a supplementary nature to the normal diet and possibly having an intended function over and above normal nutrient requirements.
Fortification refers, for the purposes of this paper, to the addition of vitamins and/or minerals to a food.
General Purpose Food refers to foods that are generally available for consumption by the population for the purpose of general nutrition and well being (eg bread, cereal).
Nutritional Equivalence means substitute foods being of similar nutritional value in terms of quantity and quality of protein and in terms of kinds, quantity and bioavailability of essential nutrients (eg margarine).
Potential Nutritional Benefit refers to potential opportunity to improve the nutrition of the population or target group based on evolving plausible scientific knowledge.
Recommended Dietary Intake refers to the levels of essential nutrient intake considered to be adequate to meet the nutritional needs of practically all healthy people.
Restoration means the addition to a food of essential nutrient(s) which are lost during the course of good manufacturing practice, or during normal storage and handling procedures.
Special Purpose Food refers to foods that have been specifically processed or formulated to satisfy particular dietary requirements, which exist because of a particular physical or physiological need (and/or specific disease and disorders) that cannot be met by consumption of a ‘normal diet’. For example pregnancy and lactation, as well as physical (including lifestyle) and physiological conditions could be considered to require the use of special purpose foods.
Substitute Food means a food which is designed to resemble another food in appearance and texture, and is intended to be used in the same way as, and as a complete or partial replacement for, the food it resembles.
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PURPOSE
The purpose of this paper is to seek public comment on the issues associated with the development of policy guidelines for the future regulation of food fortified with vitamins and minerals.
The main policy issues to be considered include:
• e protection of public health and safety;
• e current and future shape of the food supply in an environment of technological developments, changing lifestyles and consumer habits; and
• e potential consequential long-term changes to consumption patterns of food, whether fortified or not.
These issues are discussed throughout the paper.
SCOPE OF DRAFT FORTIFICATION POLICY GUIDELINES
For the purposes of this paper fortification is defined as the addition of vitamins and minerals to food. However, as policy develops in this area, comments made in response to this paper may also inform policy development on the addition of substances other than vitamins and minerals to food.
This consultation paper covers both mandatory fortification (i.e. fortification required by Government) and voluntary fortification (i.e. fortification which is permitted by government but applied at the discretion of industry).
In both cases, consideration of fortification is being discussed in the context of the addition of vitamins and minerals across the whole food supply except for special purpose food. Special purpose foods have been excluded from these considerations because their main purpose is to meet special dietary needs of particular population groups and their composition and labelling is regulated to account for the specific dietary needs of the target population. Dietary supplements regulated as complementary medicines by the Therapeutics Goods Administration in Australia are also excluded. Dietary supplements regulated under the New Zealand Dietary Supplements Regulations 1985 other than those defined for the purposes of this paper as food type dietary supplements are also excluded. Finally, fortification through genetic means is deemed to be beyond the scope of the paper.
The paper considers the implications for the development of policy regarding food-type dietary supplements to the extent that these products involve the addition of vitamins and minerals.
CONTEXT
The key factors underlying the need for a regulatory review of fortification include:
• n increase in the number of industry applications to Food Standards Australia New Zealand (FSANZ) to voluntarily fortify food products;
• s to the Australia New Zealand Food Regulation Ministerial Council to consider mandatory fortification to address significant public health issues; and
• cements in nutrition science and improvements in our understanding of health and nutrition.
Interest in fortification and related issues is also a consequence of the increased prevalence of diet- related diseases such as obesity, cardiovascular disease and diabetes. These matters are strong drivers behind the nutrition guidelines of both New Zealand and Australia which provide information to the public and health professionals about ‘healthy’ food choices, balanced diets and ‘good’ nutrition. In this paper these guidelines are jointly referred to as ‘National Nutrition Policies’.
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Domestic Setting
The Australia New Zealand Food Standards Code contains food standards that jointly apply to both Australia and New Zealand. The key standard that relates to voluntary fortification is Standard
1.3.2 - Vitamins and Minerals. This standard has evolved over time through external applications and internal review, and is based to some extent on the guidelines developed in 1987 by the international standards setting body, Codex Alimentarius Commission (Appendix A) and is a mix of risk-based and non-risk-based elements.
Further information on the domestic setting as reflected in the vitamins and minerals standard development by FSANZ is contained in Appendix B.
International Setting
Regulations for fortification are currently under review worldwide.
On 10 November, 2003 the European Union (EU) proposed a set of rules for the voluntary addition of vitamins, minerals and other substances such as herbal extracts. The rules propose that the European Food Safety Authority would assess possible risk to human health before permitted substances, other than the listed vitamins and minerals, could be added to foods. The authority would also set minimum and maximum levels and labelling requirements.
Canada is also well advanced in the review process. The United Kingdom is watching developments in New Zealand and Australia with interest and it is understood that a number of Asian countries are also considering the complexities of fortification issues.
Summary information on international developments is contained in Appendix C.
MANDATORY AND VOLUNTARY FORTIFICATION
It is widely acknowledged that the food supply can provide a useful vehicle for transporting vitamins and minerals to address public health problems, either existing or potential, or to assist in general health and well being.
There are two factors that differentiate mandatory fortification from voluntary fortification: the rationale for fortification and who decides what food will be fortified.
The Rationale for Fortification
The rationale for mandatory fortification is threefold:
• here is evidence of a significant health need;
• ere is a high probability that mandatory fortification will address this need and lead to an improved public health outcome; and