Food Standards (Application A1287 – Food derived from Short-Stature Corn Line MON94804) Variation

Administered by Department of Health, Disability and Ageing

Legislation au F2024L01312 Not in force Legislative Instrument

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EXPLANATORY STATEMENT 

 

Food Standards Australia New Zealand Act 1991 

 

Food Standards (Application A1287 – Food derived from short-stature corn line MON94804) 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 A1287 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 MON94804. Corn line MON94804 has been genetically modified to have overall reduced plant height (short-stature). The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation – the Food Standards (Application A1287 – Food derived from short-stature corn line MON94804) 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 corn line MON94804, in accordance with the Code. Corn line MON94804 has been genetically modified to have reduced overall plant height.

 

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 A1287 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 19 March 2024 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 (RIS) was not required for applications relating to GM foods, updated OIA reference: OIA23-06225. 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 A1287 – Food derived from short-stature corn line MON94804) 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 ‘(zk)’ 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 (zk) refers to ‘short-stature corn line MON94804’.

The effect of the variation is to permit the sale and use of food derived from corn line MON94804 in accordance with the Code.

 

[1] https://oia.pmc.gov.au/resources/guidance-impact-analysis/regulatory-impact-analysis-guide-ministers-meetings-and-national

Overview

The Food Standards Australia New Zealand Act 1991 was enacted to facilitate the establishment and operation of a national uniform food regulation scheme involving the Commonwealth and state governments. This Act established Food Standards Australia New Zealand (FSANZ) with the responsibility of developing food standards, which are then considered and endorsed by the Food Ministers’ Meeting (FMM). The Act aims to ensure that food regulation is consistent across Australia and New Zealand, thereby promoting public health and safety as well as facilitating trade. The legislative instrument, the Food Standards (Application A1287 – Food derived from short-stature corn line MON94804) Variation, is a draft approved by FSANZ to amend the Australia New Zealand Food Standards Code to permit the sale and use of food derived from genetically modified corn line MON94804, which is engineered for reduced plant height. The variation is not subject to disallowance or sunsetting provisions as it is intended to give effect to an intergovernmental agreement and Australia’s obligations under an international agreement. Public consultation was conducted on the application as required by the FSANZ Act, and no regulatory impact statement was deemed necessary as the changes were considered minor and deregulatory.

Scope and Application

The Food Standards Australia New Zealand Act 1991 provides the legislative framework for the establishment and operation of the Food Standards Australia New Zealand Authority (FSANZ), which is responsible for developing food standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code. The Authority's role includes accepting applications for the development or variation of food regulatory measures, including standards, and considering these applications in accordance with the procedures outlined in Division 1 of Part 3 of the FSANZ Act. This process ensures that food standards and variations are developed and endorsed by the Food Ministers' Meeting (FMM), which consists of representatives from Australia, New Zealand, and the Commonwealth and State/Territory governments. Once endorsed by the FMM, the food standards on gazettal and registration become part of the food laws in the participating jurisdictions. The Food Standards (Application A1287 – Food derived from short-stature corn line MON94804) Variation is a legislative instrument that amends the Australia New Zealand Food Standards Code to permit the sale and use of food derived from short-stature corn line MON94804. The variation is a non-disallowable instrument under section 44 of the Legislation Act 2003, exempt from disallowance or sunsetting provisions, and does not incorporate any documents by reference. The variation amends Schedule 26 of the Code by inserting a new paragraph (zk) into the table to subsection S26—3(4), which refers to 'short-stature corn line MON94804', thereby permitting the sale and use of food derived from this genetically modified corn line in accordance with the Code. The Authority has approved this draft variation following one round of public consultation and has assessed that a regulatory impact statement is not required for this application.

Key Provisions

The Food Standards (Application A1287 – Food derived from short-stature corn line MON94804) Variation under the Food Standards Australia New Zealand Act 1991 (FSANZ Act) primarily modifies the Australia New Zealand Food Standards Code to allow the sale and use of food derived from genetically modified corn line MON94804. Section 13 of the FSANZ Act establishes the Authority’s role in developing food standards, while Division 1 of Part 3 outlines the process for considering applications for the development or variation of food regulatory measures, including standards. Following this process, the Authority accepted Application A1287, which sought to amend the Code to permit the sale and use of food derived from a new genetically modified food, and subsequently approved a draft variation (section 92 of the FSANZ Act). This legislative instrument imposes specific obligations on the Authority to ensure that the standards and variations it develops comply with the FSANZ Act and the Food Regulation Agreement. The Authority must follow the outlined procedures for considering applications and must publish a notice about the draft variation, as required by section 92 of the FSANZ Act. Additionally, the Authority is mandated to coordinate with the Food Ministers’ Meeting to ensure that the proposed variations align with the national uniform food regulation scheme. The Authority is also responsible for ensuring that the variations facilitate the establishment or operation of the intergovernmental scheme and give effect to Australia’s international obligations under the agreements with New Zealand. Failure to comply with the requirements and procedures set out in the FSANZ Act and the Food Standards (Application A1287 – Food derived from short-stature corn line MON94804) Variation could result in civil or criminal consequences. While specific penalties are not detailed in the explanatory statement, non-compliance with food regulatory measures can generally lead to enforcement actions by regulators, including fines, recalls of non-compliant products, and other corrective measures. The FSANZ Act and related legislation may also provide for penalties for non-compliance, which can vary depending on the nature and severity of the breach. The approved draft variation does not incorporate any documents by reference and is not subject to disallowance or sunsetting provisions under the Legislation Act 2003. This is because it facilitates the establishment or operation of an intergovernmental scheme and gives effect to an international obligation of Australia, as specified in the FSANZ Act. The variation is a legislative instrument that is publicly available on the Federal Register of Legislation and is exempt from the requirements for a statement of compatibility with human rights. The Authority's assessment is that a regulatory impact statement is not required for this application, as it pertains to the voluntary use of a genetically modified food deemed safe.

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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.