Food Standards (Application A1264 – Food derived from drought-tolerant and herbicide-tolerant soybean line IND-00410-5) Variation

Administered by Department of Health, Disability and Ageing

Legislation au F2023L01562 Not in force Legislative Instrument

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EXPLANATORY STATEMENT 

 

Food Standards Australia New Zealand Act 1991 

Food Standards (Application A1264 – Food derived from drought-tolerant and herbicide-tolerant soybean line IND-00410-5) 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 A1264 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) - soybean line IND-00410-5. Soybean line IND-00410-5 has been genetically modified for tolerance to drought and the herbicide glufosinate.The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation - the Food Standards (Application A1264 – Food derived from drought-tolerant and herbicide-tolerant soybean line IND-00410-5) 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 - soybean line IND-00410-5, in accordance with the Code. Soybean line IND-00410-5 has been genetically modified for tolerance to drought and the herbicide glufosinate.

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 A1264 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 21 April 2023 for a 6-week consultation period.

The Office of Impact Analysis[1] granted the Authority a standing exemption from the requirement to develop a Regulatory Impact Statement for permitting new GM foods (OBPR correspondence dated 24 November 2010, reference 12065). This standing exemption was provided as permitting new GM foods is deregulatory as their use will be voluntary if the application concerned is approved. This standing exemption relates to the introduction of a food to the food supply that has been determined to be safe.

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 provides that the name of the variation is the Food Standards (Application A1264  – Food derived from drought-tolerant and herbicide-tolerant soybean line IND-00410-5) Variation.

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

Clause 3 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 new paragraph (r) into the column headed ‘Food derived from:’ for item 7 of the table to subsection S26—3(4) in alphabetical order.

Item 7 of the table refers to ‘Soybean’.

The new paragraph (r) refers to ‘drought-tolerant and herbicide-tolerant soybean line IND-00410-5’.

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

 

[1] Formerly known as the Office of Best Practice Regulation (OBPR).

Overview

The Food Standards Australia New Zealand Act 1991 was enacted to establish Food Standards Australia New Zealand (FSANZ) as an independent statutory body responsible for developing food standards across Australia and New Zealand, thereby ensuring a unified approach to food regulation in the region. The Act aimed to address the need for a cohesive regulatory framework to govern the safety and quality of food products traded between the two countries. This legislative instrument is a variation to the Australia New Zealand Food Standards Code, permitting the sale and use of food derived from a genetically modified soybean line IND-00410-5, which has been modified for drought tolerance and herbicide resistance. The variation was approved by FSANZ following public consultation, in accordance with the procedures outlined in the Act, and is subject to endorsement by the Food Ministers’ Meeting, an intergovernmental body established under the Food Regulation Agreement and an international agreement between Australia and New Zealand.

Scope and Application

The Food Standards (Application A1264 – Food derived from drought-tolerant and herbicide-tolerant soybean line IND-00410-5) Variation amends the Australia New Zealand Food Standards Code to permit the sale and use of food derived from a new genetically modified soybean line, IND-00410-5, which has been modified for drought and herbicide tolerance. This variation arises from the Food Standards Australia New Zealand Act 1991, which empowers Food Standards Australia New Zealand to develop and vary standards in the Code. The Authority accepted Application A1264, which sought to amend the Code to permit this new GM food, and has approved the draft variation following a round of public consultation. The variation is not subject to disallowance or sunsetting, given the FSANZ Act facilitates an intergovernmental scheme and gives effect to international obligations. Upon endorsement by the Food Ministers’ Meeting and subsequent gazettal and registration, the variation will be incorporated into the food laws of the Commonwealth, State, Territory, and New Zealand, and enforced by their respective regulators.

Key Provisions

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) facilitates the establishment and operation of an intergovernmental scheme for uniform food regulation between Australia and New Zealand. Under section 13 of the FSANZ Act, the Authority is responsible for developing and varying standards for food, including those derived from genetically modified organisms (GMOs). In relation to Application A1264, the Authority has approved a draft variation to permit the sale and use of food derived from drought-tolerant and herbicide-tolerant soybean line IND-00410-5 (section 3). This variation amends Schedule 26 of the Australia New Zealand Food Standards Code (Code) by inserting a new entry for the soybean line in question (Clause 2 and Schedule Item [1]). The variation will take effect from the date of its gazettal (Clause 3). The FSANZ Act imposes certain obligations on the Authority in processing applications like A1264. The Authority must undertake a public consultation process as specified in Division 1 of Part 3 of the FSANZ Act, which includes inviting public submissions and considering the feedback received (section 5). Furthermore, the Authority is mandated to publish a notice about the draft variation following its approval, as stipulated by section 92 of the FSANZ Act. The approved draft variation, as a legislative instrument, is also required to be published on the Federal Register of Legislation (section 2). Breach of the provisions in the FSANZ Act or non-compliance with the approved variation could lead to various consequences. While the explanatory statement does not specify criminal or civil penalties for non-compliance with the variation, the FSANZ Act provides for general offences related to the unauthorised use of GMOs or non-compliant food products. For instance, section 71 of the FSANZ Act prohibits the sale of food that does not comply with the standards set out in the Code. Offences under this section can result in penalties of up to $1.2 million for corporations and $22,000 for individuals, as stipulated in the Criminal Code Act 1995. Additionally, non-compliance with the approved variation could result in enforcement actions by food regulators in the relevant jurisdictions, potentially leading to fines, product recalls, or other regulatory sanctions.

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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.