Food Standards (Application A1272 – Food derived from herbicide-tolerant and insect-protected corn line DP915635) Variation

Administered by Department of Health, Disability and Ageing

Legislation au F2024L00466 Not in force Legislative Instrument

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EXPLANATORY STATEMENT 

 

Food Standards Australia New Zealand Act 1991 

 

Food Standards (Application A1272 – Food derived from herbicide-tolerant and insect-protected corn line DP915635) 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 A1272 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 DP915635. Corn line DP915635 has been genetically modified for tolerance to the herbicide glufosinate and protection from coleopteran insect pests, particularly corn rootworm. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation – the Food Standards (Application A1272 – Food derived from herbicide-tolerant and insect-protected corn line DP915635) 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 approved 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 corn line DP915635, in accordance with the Code. Corn line DP915635 has been genetically modified for tolerance to the herbicide glufosinate and protection from coleopteran 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 A1272 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 7 September 2023 for a six-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 these changes, the OIA advised FSANZ that a Regulatory Impact Statement was not required for applications relating to GM foods. 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 A1272  – Food derived from herbicide-tolerant and insect-protected corn line DP915635) 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 amends Schedule 26 of the Code by inserting, in alphabetical order, a new paragraph ‘(zh)’ 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 (zh) refers to ‘herbicide-tolerant and insect-protected corn line DP915635’.

The effect of the variation is to permit the sale and use of food derived from that corn line 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 establish Food Standards Australia New Zealand as the authoritative body for developing food standards and variations within the Australia New Zealand Food Standards Code. This Act was introduced to address the need for uniform food regulation across Australia and New Zealand, ensuring that food safety standards are consistent and effectively managed. The FSANZ Act facilitates the establishment and operation of an intergovernmental scheme involving the Commonwealth and the states, which is essential for national uniform food regulation. The policy objective is to ensure the development of food standards that protect public health and safety while also considering economic and trade implications. The FSANZ Act was enacted by the Australian Parliament and provides for the development of standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code. The Authority has the function to accept applications for the development or variation of food regulatory measures, including standards. In line with this, the Authority has approved a draft variation to permit the sale and use of food derived from a genetically modified corn line, DP915635, which has been modified for herbicide tolerance and insect protection. This variation follows a process that includes public consultation and endorsement by the Food Ministers’ Meeting. The legislative instrument is not subject to disallowance or sunsetting provisions due to its role in facilitating the intergovernmental scheme and giving effect to international obligations.

Scope and Application

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) governs the establishment and functions of Food Standards Australia New Zealand (FSANZ), which is responsible for developing food standards and variations within the Australia New Zealand Food Standards Code. This legislation applies to entities and individuals involved in the food industry, including manufacturers, processors, distributors, and retailers of food products. The FSANZ Act covers all food products intended for sale and use within Australia and New Zealand, thereby encompassing a broad spectrum of industries and transactions related to food production and distribution. The Act’s geographic reach extends to both national and intergovernmental levels, ensuring uniformity and compliance across jurisdictions through the Food Regulation Agreement. The FSANZ Act does not specify particular exclusions or exemptions, but the legislative process, including the endorsement by the Food Ministers’ Meeting (FMM), ensures that variations such as the Food Standards (Application A1272 – Food derived from herbicide-tolerant and insect-protected corn line DP915635) Variation adhere to stringent safety and regulatory standards. The FSANZ Act enables the creation of subordinate instruments that can extend or restrict application, ensuring that food standards remain dynamic and responsive to new scientific evidence and technological advancements.

Key Provisions

The main operative sections of the Food Standards (Application A1272 – Food derived from herbicide-tolerant and insect-protected corn line DP915635) Variation (FSANZ Act) involve the amendment of the Australia New Zealand Food Standards Code (the Code) to permit the sale and use of food derived from a genetically modified corn line, specifically DP915635, which has been modified for herbicide tolerance and insect protection. The Authority, Food Standards Australia New Zealand, accepted Application A1272 under Section 13 of the FSANZ Act, which outlines the Authority's functions to develop and vary standards within the Code. This application sought to amend the Code to allow for the use of this specific genetically modified corn line, DP915635, which has been modified to be tolerant to the herbicide glufosinate and resistant to coleopteran insect pests, particularly corn rootworm. The Authority has approved a draft variation to incorporate these changes into the Code, following the stipulated procedures in Division 1 of Part 3 of the FSANZ Act. The FSANZ Act imposes specific obligations on Food Standards Australia New Zealand to develop and vary food standards in consultation with relevant stakeholders, including public consultation as required. Section 92 of the FSANZ Act mandates that once a draft variation is approved, the Authority must publish a notice about the approved draft variation. This ensures transparency and allows for public scrutiny and feedback on the changes proposed. Furthermore, the Authority is obligated to consider applications for the development or variation of food regulatory measures, ensuring that any new food products, particularly those derived from genetically modified organisms (GMOs), are assessed for safety and compliance with food standards. The Authority's role is crucial in maintaining the integrity and safety of the food supply in Australia and New Zealand. Under the FSANZ Act, breaches of the Food Standards Code or non-compliance with the approved variations could lead to civil or criminal penalties. While the specific penalties are not detailed in the explanatory statement, the FSANZ Act and associated regulations typically impose fines and other sanctions for non-compliance. For instance, breaches of food standards can result in significant financial penalties, with the exact amount depending on the severity and frequency of the breach. Additionally, failure to comply with food safety standards can lead to criminal charges, which may include imprisonment. The FSANZ Act ensures that there are consequences for non-compliance, thereby reinforcing the importance of adhering to the established food standards to protect public health and safety. The approved draft variation is a legislative instrument, exempt from disallowance and sunsetting provisions under the Legislation Act 2003. This exemption is due to the FSANZ Act facilitating the establishment or operation of an intergovernmental scheme involving the Commonwealth and one or more States, and the Act's role in giving effect to Australia's international obligations. The FSANZ Act establishes the Authority to develop food standards, which are then considered and endorsed by the Food Ministers’ Meeting (FMM). If endorsed by the FMM, these standards become part of the food laws in the Commonwealth, States, Territories, and New Zealand. The FSANZ Act, by giving effect to the Food Regulation Agreement and international agreements between Australia and New Zealand, ensures a unified approach to food regulation across these jurisdictions. The approved draft variation, being a legislative instrument, supports this framework by amending the Code to include the new genetically modified corn line, DP915635, and thereby facilitating its sale and use in accordance with the Code.

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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.