Comments invited on declaring goods to be therapeutic goods

A review of the definition of "foods" in the Therapeutic Goods Act 1989, is underway through the External Reference Panel on Therapeutic Goods/Foods Interface Matters (ERPIM). ERPIM is an advisory panel to provide advice on interface matters to TGA and the Australia New Zealand Food Authority (ANZFA). It consists of representatives from TGA, ANZFA, State, Territory and New Zealand health authorities, the Australian Quarantine Inspection Service, industry and consumers. In the meantime ERPIM is proposing three products be declared to be therapeutic goods and seeks public comment on the proposal.

This activity is in direct response to the recommendations of the 1996 Review of the Therapeutic Goods Administration. The objective is to streamline decisions about whether a product is a 'food' or a medicinal product which will provide greater certainty for industry and regulators. It addresses the problems of the protracted decision making process on a product by product basis that industry has, at times in the past, experienced.

Section 7 of the Therapeutic Goods Act, 1989 provides for the Secretary to make a declaration on the status of a good if the Secretary is satisfied that the particular good or classes of good is, or is not, a therapeutic good. Declarations are published in the Commonwealth Gazette.

Process for managing a proposal for section 7 declarations

1. A proposal to make a section 7 declaration may originate from the External Reference Panel on Therapeutic Goods/Foods Interface Matters (ERPIM), industry, ANZFA or TGA.
2. The proposal will be managed by the Complementary Medicines Section of TGA.
3. Notice that the proposal is being considered will be published in appropriate newsletters of TGA and ANZFA and circulated to industry associations and other stakeholder bodies inviting comment on it.
4. The proposal would be put to the Complementary Medicines Evaluation Committee and the TGA would consider its recommendations.
5. The Secretary may then make a decision with respect to the proposal.
6. If the Secretary makes a declaration, it will be published in the Commonwealth Gazette, to take effect on the date of publication.
7. Gazette notices and the reasons for the declarations will be more widely published for industry and stakeholder information (as above).

ERPIM has recommended that TGA prepare section 7 declarations that the following goods be therapeutic goods in accordance with the above process:

1. Goods for oral use labelled or promoted as being a source of fibre and supplied in capsule, tablet or pill form.
2. Goods for oral use:
   1. containing isolated selenium; or
   2. labelled or promoted as containing selenium;
   other than where standardised in the Food Standards Code.
3. Goods for oral use:
   1. containing isolated shark cartilage; or
   2. labelled or promoted as containing shark cartilage;
   other than where standardised in the Food Standards Code.

Prior informed consent - update

The fourth Intergovernmental Negotiating Committee on Prior Informed Consent met in Rome in October 1997. The Australian delegation included representatives of the Departments of: Foreign Affairs and Trade, Health and Family Services, Primary Industry and Energy, and Environment, Sport and Territories. The Prior Informed Consent Procedure is an international programme which requires countries which take national action to ban or severely restrict a chemical on health or environmental grounds, to notify this action on a product by product basis. This information on the action taken, and the reasons for the action, are supplied to a Secretariat which is jointly run by the United Nations Environment Programme (UNEP) and the Food and Agriculture Organisation (FAO). When notifications have been received, and the evidence of the health or environmental concerns has been considered, the chemical may be placed on an international list. Countries then have the opportunity to notify whether they wish to continue to receive the chemical or not. International negotiations are continuing to change the voluntary procedure to a legally binding process.

Discussions progressed in the fourth meeting. There was agreement on the need for an export notification system for chemicals which are banned or severely restricted in the country of export, although no agreement on the form or frequency of export notification could be reached. Progress was made on determining the criteria for listing a chemical on the international list. There was significant discussion on what information should be considered confidential, and Australia expressed concern over a requirement to protect proprietary rights. In general, positions were more clearly defined at the fourth meeting, and countries are aware of the areas which will require compromises at the next meeting.

Importantly, there was no discussion of the current proposal for the exemption of all pharmaceuticals (given their control under other international instruments). However, this will not be finally negotiated until the fifth meeting, to be held in Brussels in either January or February next year.

C&NPD Branch publications

Handbook for First Aid Instructions ind Safety Directions for Agriculture and Veterinary Chemicals (Including Pesticides)

First Edition (November 1996)

The Handbook of First Aid Instructions and Safety Directions for Agricultural and veterinary Chemicals (including Pesticides) is now available. It contains details of first aid instructions and safety directions recommended to the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) by the Therapeutic Goods Administration (TGA) for inclusion on the labels of agricultural and veterinary chemicals.

This information was previously published as Appendixes E and H to the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). It includes all entries previously included in the SUSPD, together with subsequent amendments established by the Department of Health and Family Services, TGA and Worksafe Australia up to the date of the publication.

This guide has been specifically prepared to assist manufacturers and packers of agricultural and veterinary chemicals and pesticides to draft first aid and safety directions for labels for these products.

ADI List

Acceptable daily intakes for agricultural and veterinary chemicals

April 1997

The ADI List is now available. It sets out the acceptable daily intakes (ADI's) for agricultural and veterinary chemicals used on food producing crops or animals. It includes figures which were recommended by the former Pesticides and Agricultural Chemicals Standing Committee (PACSC) of the National Health and Medical Research Council (NHMRC) until November 1992.

The responsibility for setting ADI's transferred to the Therapeutic Goods Administration (TGA) of the Commonwealth Department of Health and Family Services on 12 March 1994. ADI's established by TGA are included in this document.

The ADI List is an essential reference for companies marketing agricultural and veterinary chemicals, for regulatory agencies and for those with an interest in levels of agvet chemicals allowed in foods.