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Initial Assessment Report Proposal P235 Review Of 10/02 26 June 2002 INITIAL ASSESSMENT REPORT (PREPARE A NEW PROPOSAL - SECTION 21) PROPOSAL P235 REVIEW OF FOOD-TYPE DIETARY SUPPLEMENTS DEADLINE FOR PUBLIC SUBMISSIONS to the Authority in relation to this matter: 7 AUGUST 2002 (See ‘Invitation for Public Submissions’ for details) THE AUSTRALIA NEW ZEALAND FOOD AUTHORITY The Australia New Zealand Food Authority’s (ANZFA) role is to protect the health and safety of people in Australia and New Zealand by maintaining a safe food supply. ANZFA is a partnership between the Commonwealth Government, Australian States and Territories governments and the New Zealand Government. As an independent expert body, ANZFA is responsible for developing and reviewing food standards for both Australia and New Zealand. ANZFA makes recommendations to change the food standards to the Australia New Zealand Food Standards Council, a Ministerial Council made up of Commonwealth, State and Territory and New Zealand Health Ministers. If the Council approves the recommendations made by ANZFA, the food standards are automatically adopted as regulations into the food laws of the Australian States and Territories and New Zealand. ANZFA’s OBJECTIVES In developing or varying a food standard, ANZFA is required by its legislation to meet three primary objectives, which are set out in section 10 of the Australia New Zealand Food Authority Act 1991. These are: S the protection of public health and safety; S the provision of adequate information relating to food to enable consumers to make informed choices; and S the prevention of misleading or deceptive conduct. In developing and varying standards, ANZFA must also have regard to: S the need for standards to be based on risk analysis using the best available scientific evidence; S the promotion of consistency between domestic and international food standards; S the desirability of an efficient and internationally competitive food industry; and S the promotion of fair trading in food. OTHER REGULATORY OBJECTIVES At the same time ANZFA must ensure that the regulations it develops are the most efficient and effective possible. It does this by looking at the possible impact that the regulation might have on consumers, business and other groups in our community or whether there are alternative options to formal regulations such as codes of practice. In addition, as Australia and New Zealand are members of the World Trade Organization (WTO), ANZFA must ensure that the regulations are consistent with the obligations of both countries as members of the WTO. 2 TABLE OF CONTENTS LIST OF FIGURES.............................................................................................................. 4 LIST OF TABLES ............................................................................................................... 4 FOOD STANDARDS SETTING IN AUSTRALIA AND NEW ZEALAND................... 5 INVITATION FOR PUBLIC SUBMISSIONS...................................................................6 Content of Submissions ......................................................................................................... 7 Transparency.......................................................................................................................... 7 Deadlines................................................................................................................................. 7 Delivery of Submissions.........................................................................................................8 FURTHER INFORMATION ............................................................................................... 8 EXECUTIVE SUMMARY ................................................................................................... 9 1. INTRODUCTION ................................................................................... 10 2. ISSUES .....................................................................................................11 2.1 Nature of product .................................................................................... 12 2.1.1 Market scan................................................................................................ 14 2.2 Current regulatory status ....................................................................... 15 2.3 International Regulations .......................................................................16 2.4 Regulatory framework ................................................................................................ 17 2.4.1 Addition of nutritive substances ............................................................................... 19 2.4.2 Special Purpose foods............................................................................................... 21 2.4.3 Formulated caffeinated beverages............................................................................. 22 2.4.4 Novel foods............................................................................................................... 23 2.4.5 Botanicals and natural toxicants ............................................................................... 24 2.4.6 Food additives and processing aids.......................................................................... 26 2.4.7 Labelling and claims ................................................................................................. 28 2.5 The regulatory problem ................................................................................................ 32 3. REGULATORY OBJECTIVES ....................................................................................33 3.1 Objectives for a joint regulatory arrangement for Food-type Dietary Supplements (FTDS)............................................................................................................33 4 REGULATORY OPTIONS....................................................................33 5 IMPACT ANALYSIS.............................................................................. 37 5.1 Affected Parties........................................................................................ 37 5.2 Impact Analysis........................................................................................37 5.2.1 Data Collection.......................................................................................... 38 6 CONSULTATION...................................................................................39 6.1 External Advisory Groups......................................................................40 6.2 Invitation for Public Submissions ..........................................................40 6.3 International and World Trade Organization...................................... 40 7 CONCLUSION........................................................................................ 41 ATTACHMENT 1 .......................................................................................................... 42 ATTACHMENT 2 .......................................................................................................... 47 ATTACHMENT 3 .......................................................................................................... 60 ATTACHMENT 4 .......................................................................................................... 66 ATTACHMENT 5 .......................................................................................................... 70 ATTACHMENT 6 .......................................................................................................... 76 3 LIST OF FIGURES Figure 1 Continuum of foods to therapeutic products. 8 Figure 2 Conceptualisation of risk assessment-based framework that currently 15 supports the Food Standards Code. Figure 3 Theoretical continuum of nutrition and health related claims. 27 Figure 4 Schematic representation of possible regulatory options for food-type 31 dietary supplements. LIST OF TABLES Table 1 Consultation documents relating to dietary supplements. 7 Table 2 Some differences in general labelling requirements for foods (Volume 2) 26 and dietary supplements (NZDSR). 4 FOOD STANDARDS SETTING IN AUSTRALIA AND NEW ZEALAND The Governments of Australia and New Zealand entered an Agreement in December 1995 establishing a system for the development of joint food standards. On 24 November 2000, Health Ministers in the Australia New Zealand Food Standards Council (ANZFSC) agreed to adopt the new Australian New Zealand Food Standards Code. The new Code was gazetted on 20 December 2000 in both Australia and New Zealand as an alternate to existing food regulations until December 2002 when it will become the sole food code for both countries. It aims to reduce the prescription of existing food regulations in both countries and lead to greater industry innovation, competition and trade. Until the joint Australia New Zealand Food Standards Code is finalised the following arrangements for the two countries apply: • Food imported into New Zealand other than from Australia must comply with either Volume 1 (known as Australian Food Standards Code) or Volume 2 (known as the joint Australia New Zealand Food Standards Code) of the Australian Food Standards Code, as gazetted in New Zealand, or the New Zealand Food Regulations 1984, but not a combination thereof. However, in all cases maximum residue limits for agricultural and veterinary chemicals must comply solely with those limits specified in the New Zealand (Maximum Residue Limits of Agricultural Compounds) Mandatory Food
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