Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 9, Num. 3, 1999

The ANZFA Position

Code Number:AU99012

The Australia New Zealand Food Authority (ANZFA) completed in 1998 its assessment of the Proposal (P97) to establish a standard to regulate food produced using gene technology.

ANZFA recommended to the Australia New Zealand Food Standards Council (ANZFSC) that it adopt the standard into the Food Standards Code. ANZFSC consists of the Commonwealth of Australia, Australian State and Territory, and New Zealand Health Ministers. The ANZFSC accepted the Authority's recommendation at its meeting on 30 July 1998.

In Australia, the standard (Standard A18) was gazetted as Amendment #40 to the Food Standards Code published on 13 August 1998 (see Attachment 1). In New Zealand the decision was gazetted on 20 August 1998 as a mandatory standard. The standard came into effect nine months after the date of gazettal, on the 13 May 1999.

The standard makes it illegal to sell any food produced using gene technology unless an application is made to ANZFA and approval subsequently given by ANZFSC. The approval process is open, consultative and based on a scientific risk assessment undertaken by ANZFA. Public comment on each application will be invited during its assessment process.

The standard contains a provision for labelling in circumstances where the nature of the food has been significantly changed with respect to its nutritional quality, composition, allergenicity, or end use. There is broad community and regulatory acceptance, both domestically and internationally, that mandatory labelling in these circumstances is warranted.

ANZFA's reasons for recommending the standard to the ANZFSC were:

• the current regulatory framework is inadequate to ensure that foods produced using gene technology undergo a safety assessment before they are released onto the market;
• the standard establishes a mechanism whereby consumers can be confident that the safety of foods produced using gene technology will be fully assessed before these products are made available for sale;
• industry will be provided with a clear regulatory pathway for the assessment of food produced using gene technology; and
• consumers will have access to accurate information, including labelling, on foods produced using gene technology.

The standard prescribes mandatory labelling for foods that contain new and altered genetic material and which are not substantially equivalent to their conventional counterparts in a characteristic or property of the food.

Where the standard specifies that a food produced using gene technology must be labelled, that label must indicate the biological origin and nature of the characteristic or property modified.

Negative claims (eg, that foods are not, or do not contain, genetically modified material) are permitted, provided they do not contravene existing fair trading laws relating to consumer deception.

The standard does not regulate food additives and processing aids that are derived from genetically modified organisms (GMO). This is because other standards in the Food Standards Code regulate these substances.

ANZFA has developed guidelines for the risk-based, case-by-case assessment of foods to be included in the Standard. These guidelines are contained in the information paper Guidelines for the Safety Assessment of foods to be included in Standard A18 - Food Produced Using Gene Technology.

On 3 August, the Australia New Zealand Food Standards Council (ANZFSC) agreed to extend the labelling of all food produced using gene technology. ANZFSC is made up of the ministers of health from the Australian States and Territories and New Zealand and is chaired by Senator, the Hon.Grant Tambling, Parliamentary Secretary to the Minister for Health and Aged Care.

ANZFSC has asked that an inter-governmental task force on the labelling of foods produced using gene technology be established to further develop the Council's recommendations to amend the Food Standards Code. The Australia New Zealand Food Authority (ANZFA) will be working closely with Australian and New Zealand government health authorities and other bodies in developing advice. This advice is to be presented to the Council at its next meeting in October 1999.

In preparing the draft amendments, the task force will consider the following issues:

• methods of labelling which are both practical and meaningful and which achieve the lowest possible compliance costs;
• methods of providing consumers with meaningful information where food is of uncertain origin, that is, where it is not known if the foodcontains genetically modified material. Options might include point of sale information,education campaigns to supplement the standard, and the development of an industry code of practice;
• criteria for the labelling of foods as containing no genetically modified ingredients, to ensure the validity of such claims;
• measures enabling manufacturers to establish the origin of food ingredients particularly in instances where food products are identified as possibly containing genetically modified ingredients;
• identification of the compliance costs to both industry and governments of implementing the standard;
• means of testing foods for compliance and enforcement of the new standard;
• implications of the new standard for Australia and New Zealand under their agreements with the World Trade Organisation;
• identification of a minimum, or threshold, level of genetically modified content of a food above which mandatory labelling is required; and
• provisions for the sunset or the review of the new standard.

ANZSFC recognises that the introduction of a comprehensive system for the labelling of foods produced using gene technology will take some time. In the past, ANZFSC has usually allowed a period of 12 months for a change to labelling to allow industry sufficient time to amend food labels.

This labelling decision followed a Health Ministers' meeting on 17 December 1998 where ANZFSC, by a majority vote, directed ANZFA to require labelling of genetically modified food where it is substantially equivalent, by developing a draft amendment to the Food Standards Code which takes into account the need to:

(a) label if the manufacturer knows the food contains genetically modified material; and

(b) if the manufacturer is uncertain about the food's contents, they must indicate that the food may contain genetically modified material.

ANZFA carried out public consultation on the issue of labelling over a 4 week period between 17 May and 11 June. The New Zealand Ministry of Health conducted a similar consultation in New Zealand between 10 May and 4 June.

On 30 March 1999 the ANZFSC stated that most international biotechnology companies had been unacceptably slow in presenting their genetically modified commodities for assessment by ANZFA. Their tardiness was placing local businesses in an invidious position of either having to remove their products from the marketplace - causing chaos in supermarkets - or risk prosecution for selling unapproved foods after 13 May 1999 when the standard took effect.

The ANZFSC agreed to amend Standard A18 by incorporating three firm requirements in order for any genetically modified commodity to remain on the market from 13 May 1999. These are:

1. Companies must have submitted a comprehensive application for a safety assessment of their foods to ANZFA by 30 April 1999;

2. The food commodity must already be on the market lawfully overseas and be considered safe by an overseas regulatory agency; and

3. ANZFSC must have no evidence to indicate that the food commodity is unsafe.

By 30 April 1999, ANZFA had received 13 applications in addition to 7 which had been with the Authority for some time. A full list of applications is at Attachment 2.

ANZFA considers that these 20 applications cover the genetically modified crops likely to be imported or used within foods in Australia and New Zealand. All applications have met the regulatory requirements for foods produced using gene technology in one or more the following countries: USA, Canada, Japan and the European Union.

ANZFA is now progressing on assessments for each of these applications and they are at varying stages of completion.

Australia and New Zealand are members of the WTO and are bound as parties to WTO agreements. In Australia an agreement developed by the Council of Australian Governments (COAG) requires States and Territories to be bound as parties to those WTO agreements to which the Commonwealth is a signatory. Under the agreement between the Governments of Australia and New Zealand on Uniform Food Standards, ANZFA is required to ensure that food standards are consistent with the obligations of both countries as members of the WTO.

Consistent with these obligations, Standard A18, developed under the Authority's Proposal P97, was notified to the WTO in April 1997 as a Sanitary and PhytoSanitary Notification. Further notifications on this issue were made in March 1999 and again in May 1999 as Technical Barriers to Trade Notifications.

Further information on ANZFA and its procedures in relation to foods produced using gene technology can be found on the ANZFA web site at www.anzfa.gov.au

Requests for further information on this and other food standards matters should be directed in the first instance to the Authority's Standards Liaison Officer on 02 6271 2258 or Email: slo@anzfa.gov.au

Public documents relating to foods produced using gene technology released by the Authority include:

• Fact Sheet: The Labelling of Foods Produced using Gene Technology
• Fact sheet: Safety Assessment of Genetically Modified (GM) Foods
• Safety Assessment guidelines for foods to be included in Standard A18 - Food Produced Using Gene Technology
• Explanatory Notes 17 February 1999 - Application A338
• Information Summary 28 October 1998 - Applications A338, A355, A341, A346, A362 and A363

Copyright 1999 Australian Biotechnology Association Ltd.