P235IAR-exec Summary

Full Report [ PDF format 485 kb ]

Executive summary

Volumes 1 and 2 of the Food Standards Code do not currently regulate many foods that are considered to be dietary supplements. Many such products are manufactured in or imported into New Zealand under the New Zealand Dietary Supplement Regulations 1985 (NZDSR) and from there, into Australia under the Trans Tasman Mutual Recognition Arrangement (TTMRA). This Proposal (P235) seeks to develop food regulatory measures to manage thesefood-typedietary supplements (FTDS) within the context of the harmonisation of food regulations between Australia and New Zealand.

Viewed more broadly, foods such as those

manufactured tothe NZDSR represent a growing sector of the global food market and present a number of international regulatory challenges. codex Alimentarius has not established a specific standard for these products and international regulatory measures differ markedly between countries.

This paper considers the current permissions of the NZDSR in the context of possible measures that could be used to regulate FTDS. Four main options for the regulation of FTDS are presented. Options 2 and 3 are based on the premises that:

a) the New Zealand Food Regulations 1984 will be repealed at the end of the transition period (end 2002); and

b) the NZDSR will be revoked or amended in due course such that products presented as ' foods' could no longer be manufactured, imported or marketed specifically under these regulations.

Option 1 is based on premise a) only.

In the interests of exploring these options as fully as possible prior to the development of any draft regulatory measures, option 2 is further expanded into sub-options that address management of FTDS through either expansion of the general permissions of the current standards, or development of new standards in the Food Standards Code.

Any assessment of possible regulatory options requires consideration of the current permissions in the NZDSR and/or Volume 2 for: addition of certain substances to foods, in particular, nutritive substances and further botanical substances; novel foods; relevant products such as formulated supplementary sports foods and formulated caffeinated beverages (FCBs); and aspects of labelling and associated claims. These are outlined in Section 2.4. Furthermore, this proposal needs to carefully consider the boundary that exists between food-type- and therapeutic-type dietary supplements (TTDS) (such as complementary medicines).

At the same time that ANZFA is considering trans-Tasman harmonisation of foods, the Joint Therapeutic Products Agency (JTA) team (a preliminary working group formed between respective therapeutic products agencies in Australia and New Zealand) is also developing a proposal for harmonised regulation of medicines. This project will be specifically considering TTDS whilst, P235 considers FTDS i.e. foods. Furthermore, the New Zealand Ministry of Health will be considering the NZDSR, specifically in relation to foods that may be sold under these regulations.

Therefore, in order to provide a more ' complete picture' , it is anticipated there will be three consultation documents released at a similar time for consideration by the community. Table 1 below summarises the respective documents and authoring agencies.

Table 1. Consultation documents relating to dietary supplements.

Following receipt of submissions to P235, proposed draft food regulatory measures will be prepared and circulated by ANZFA for further consideration within the context of the Draft Assessment Report for P235.

Full Report [ PDF format 485 kb ]