Food Standards (Application A1280 – Food derived from herbicide-tolerant and insect-protected corn line DAS1131) Variation

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Legislation au F2024L00895 In force Legislative Instrument

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EXPLANATORY STATEMENT 

 

Food Standards Australia New Zealand Act 1991 

 

Food Standards (Application A1280 – Food derived from herbicide-tolerant and insect-protected corn line DAS1131) Variation  

 

1. Authority

 

Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) provides that the functions of Food Standards Australia New Zealand (the Authority) include the development of standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code (the Code).

 

Division 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering an application for the development or variation of food regulatory measures.

The Authority accepted Application A1280 which sought to amend the Code to permit the sale and use of food derived from a new food produced using gene technology (GM food) – corn line DAS1131. Corn line DAS1131 has been genetically modified for tolerance to the herbicide glyphosate and protection from lepidopteran insect pests. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation – the Food Standards (Application A1280 – Food derived from herbicide-tolerant and insect-protected) Variation.

 

Following consideration by the Food Ministers’ Meeting (FMM), section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the draft variation.

 

2. Variation is a legislative instrument

 

The approved draft variation is a legislative instrument for the purposes of the Legislation Act 2003 (see section 94 of the FSANZ Act) and is publicly available on the Federal Register of Legislation (www.legislation.gov.au).

 

This instrument is not subject to the disallowance or sunsetting provisions of the Legislation Act 2003. Subsections 44(1) and 54(1) of that Act provide that a legislative instrument is not disallowable or subject to sunsetting if the enabling legislation for the instrument (in this case, the FSANZ Act): (a) facilitates the establishment or operation of an intergovernmental scheme involving the Commonwealth and one or more States; and (b) authorises the instrument to be made for the purposes of the scheme. Regulation 11 of the Legislation (Exemptions and other Matters) Regulation 2015 also exempts from sunsetting legislative instruments a primary purpose of which is to give effect to an international obligation of Australia.

 

The FSANZ Act gives effect to an intergovernmental agreement (the Food Regulation Agreement) and facilitates the establishment or operation of an intergovernmental scheme (national uniform food regulation). That Act also gives effect to Australia’s obligations under an international agreement between Australia and New Zealand. For these purposes, the Act establishes the Authority to develop food standards for consideration and endorsement by the FMM. The FMM is established under the Food Regulation Agreement and the international agreement between Australia and New Zealand, and consists of New Zealand, Commonwealth and State/Territory members. If endorsed by the FMM, the food standards on gazettal and registration are incorporated into and become part of Commonwealth, State and Territory and New Zealand food laws. These standards or instruments are then administered, applied and enforced by these jurisdictions’ regulators as part of those food laws.

 

3. Purpose

 

The Authority has approved a draft variation amending the table to subsection S26—3(4) in Schedule 26 of the Code to permit the sale and use of food derived from a new GM food – corn line DAS1131, in accordance with the Code. Corn line DAS1131 has been genetically modified for tolerance to the herbicide glyphosate and protection from lepidopteran insect pests.

 

4. Documents incorporated by reference

 

The approved draft variation does not incorporate any documents by reference.

 

5. Consultation

 

In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of application A1280 included one round of public consultation following an assessment and the preparation of a draft Standard and associated report. Submissions were called for on 15 December 2023 for an eight-week consultation period.

 

Changes have been made to the Impact Analysis requirements by the Office of Impact Analysis (OIA)[1]. Impact analysis is no longer required to be finalised with the OIA. Prior to those changes, the OIA advised FSANZ that a Regulatory Impact Statement was not required for applications relating to GM foods - previous OIA reference number: 12065. This is because applications relating to permitting the use of GM foods that have been determined to be safe are considered to be minor and deregulatory in nature, as the use of the GM food will be voluntary if the draft variation related to the application is approved. Under the new approach, FSANZ’s assessment is that a regulatory impact statement is not required for this application.

 

6. Statement of compatibility with human rights

 

This instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 44 of the Legislation Act 2003.

 

7. Variation

 

Clause 1 of the variation provides that the name of the variation is the Food Standards (Application A1280 – Food derived from herbicide-tolerant and insect-protected corn line DAS1131) Variation.

Clause 2 of the variation provides that the Code is amended by the Schedule to the variation.

Clause 3 of the variation provides that the variation will commence on the date of gazettal of the instrument.

Item [1] of the Schedule to the variation would amend Schedule 26 by inserting, in alphabetical order, a new paragraph ‘(zi)’ into the column headed ‘Food derived from:’ for item 2 of the table to subsection S26—3(4) of the Code. Item 2 of this table is headed ‘Corn’.

The new paragraph (zi) refers to ‘herbicide-tolerant and insect-protected corn line DAS1131’.

The effect of the variation is to permit the sale and use of food derived from corn line DAS1131 in accordance with the Code.

[1] Regulatory Impact Analysis Guide for Ministers’ Meetings and National Standard Setting Bodies | The Office of Impact Analysis (pmc.gov.au)

Overview

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) was enacted to provide a unified framework for food regulation between Australia and New Zealand, establishing Food Standards Australia New Zealand (FSANZ) as the central body responsible for developing and maintaining the Australia New Zealand Food Standards Code. This Act aimed to address the need for harmonised food standards across both countries to facilitate trade and ensure consumer safety. The Authority, established under the FSANZ Act, is responsible for developing food standards, which are then subject to endorsement by the Food Ministers’ Meeting (FMM) and incorporated into national food laws. The explanatory statement outlines the FSANZ Act's procedure for considering applications for variations to food standards, such as Application A1280, which seeks to permit the sale and use of food derived from a new genetically modified corn line, DAS1131. The Authority’s approval of this application and the subsequent draft variation is a legislative instrument that facilitates the national uniform food regulation scheme and aligns with Australia’s international obligations.

Scope and Application

The Food Standards Australia New Zealand Act 1991 applies to the establishment and operations of Food Standards Australia New Zealand (FSANZ), which is tasked with developing food standards and variations of standards for the Australia New Zealand Food Standards Code. This Act extends to the Commonwealth, States, Territories, and New Zealand, facilitating a national uniform food regulation scheme. The Authority is empowered to accept and consider applications for the development or variation of food regulatory measures, including standards, and subsequently propose variations to the Code. The geographic reach of this Act is national, involving intergovernmental cooperation and adhering to international obligations. This particular variation, the Food Standards (Application A1280 – Food derived from herbicide-tolerant and insect-protected corn line DAS1131) Variation, seeks to amend the Code to permit the sale and use of food derived from genetically modified corn line DAS1131, which has been engineered for tolerance to glyphosate herbicide and protection from lepidopteran insect pests. The variation is not subject to disallowance or sunsetting provisions, as outlined in the Legislation Act 2003, and is exempt from the requirement for a statement of compatibility with human rights. The Authority's consideration of the application included public consultation, and an impact analysis was deemed unnecessary due to the voluntary nature of GM food use.

Key Provisions

The primary operative sections of the Food Standards (Application A1280 – Food derived from herbicide-tolerant and insect-protected corn line DAS1131) Variation, under the Food Standards Australia New Zealand Act 1991 (FSANZ Act), involve amending the Australia New Zealand Food Standards Code (Code) to include the new genetically modified (GM) corn line DAS1131. This amendment is detailed in Clause 2 of the variation and is reflected in the Schedule, which specifies the insertion of a new paragraph into the Code's Schedule 26 (Item [1]). This variation permits the sale and use of food derived from this new GM corn line, which has been genetically modified for herbicide tolerance and insect protection. The Authority has considered this application under section 13 of the FSANZ Act and, after public consultation and endorsement by the Food Ministers’ Meeting, approved the draft variation. The Act imposes specific obligations on Food Standards Australia New Zealand (the Authority), including the requirement to consider applications for the development or variation of food regulatory measures, as outlined in Division 1 of Part 3 of the FSANZ Act. The Authority must follow the stipulated procedures, which involve assessing applications, preparing draft standards, and engaging in public consultation. Once an application is approved, the Authority is mandated to publish a notice about the draft variation, as stipulated in section 92 of the FSANZ Act. The Authority also needs to ensure that the new GM food is safe for consumption, which is a critical aspect of the approval process. Under the FSANZ Act, breaches of the approved variation or non-compliance with the requirements of the Code can lead to civil and criminal consequences. Although specific penalties are not detailed in the explanatory statement, breaches of food standards regulations generally can result in significant penalties. For example, under the FSANZ Act, a corporation can be fined up to $2,100,000 for serious or repeated breaches. Additionally, individuals involved in the manufacture or sale of non-compliant food products may face criminal charges, leading to fines and imprisonment. The FSANZ Act also provides for the enforcement of these provisions through the courts, ensuring compliance with the amended standards. The approved draft variation is a legislative instrument that is not subject to disallowance or sunsetting provisions under the Legislation Act 2003. This is because the FSANZ Act facilitates the establishment and operation of an intergovernmental scheme involving the Commonwealth and one or more States, and authorises the instrument to be made for the purposes of the scheme. Furthermore, the Act gives effect to an international obligation of Australia, which exempts the instrument from sunsetting. This legislative framework ensures that the variation remains in effect until it is formally amended or repealed, providing stability and continuity in the regulation of GM foods in Australia.

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Food Law
Instrument
Regulation
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Definitions & Interpretation
Regulatory Standards
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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.