Food Standards (Application A1291 – Glucoamylase from GM Aspergillus niger as a processing aid) Variation

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Explanatory Statement

EXPLANATORY STATEMENT

 

Food Standards Australia New Zealand Act 1991

Food Standards (Application A1291 – Glucoamylase from GM Aspergillus niger as a processing aid) 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 A1291 which sought to amend the Code to permit the use of a protein engineered variant of the enzyme glucoamylase (EC 3.2.1.3) from a genetically modified Aspergillus niger containing the glucoamylase gene from Gloeophyllum sepiarium as a processing aid for use in: baking; brewing; distilled alcohol production;  and starch processing to produce glucose syrups and other starch hydrolysates. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation: the Food Standards (Application A1291 – Glucoamylase from GM Aspergillus niger as a processing aid) Variation (the approved draft 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 to amend the table to subsection S18––9(3) of the Code to permit the use of a protein engineered variant of the enzyme glucoamylase (EC 3.2.1.3) produced by a genetically modified Aspergillus niger containing the glucoamylase gene from Gloeophyllum sepiarium as a processing aid for use in: baking; brewing; distilled alcohol production; and starch processing to produce glucose syrups and other starch hydrolysates.

This permission is subject to the condition that the maximum permitted level or amount of the enzyme that may be present in the food must be consistent with good manufacturing practice (GMP).

4. Documents incorporated by reference

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

However, existing provisions of the Code incorporate documents by reference that would prescribe identity and purity specifications for the processing aid to be permitted by the approved draft variation. Section 1.1.1—15 of the Code requires substances used as processing aids to comply with any relevant identity and purity specifications listed in Schedule 3 of the Code. Section S3—2 of Schedule 3 incorporates by reference the specifications listed in the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications (FAO/WHO 2021) and the United States Pharmacopeial Convention (2022) Food Chemicals Codex (13th edition). These include general specifications for the identity and purity parameters of enzyme preparations used in food processing.

5. Consultation

In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1291 included one round of public consultation following an assessment, and the preparation of a draft variation to the Code and associated assessment summary. FSANZ called for submissions on the draft variation between 27 August and 24 September 2024. Further details of the consultation process, the issues raised during consultation and by whom, and the Authority’s response to these issues are available in an approval report published on the Authority’s website at www.foodstandards.gov.au.

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 needed for applications relating to processing aids and genetically modified food. This is because applications relating to permitting the use of processing aids and genetically modified food that have been determined to be safe are minor and deregulatory in nature, as their use will be voluntary if the draft variation concerned is approved.

Under this approach, FSANZ’s assessment is that a RIS is not needed 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

References to ‘the variation’ in this section are references to the approved draft variation.

Clause 1 provides that the name of the variation is the Food Standards (Application A1291 – Glucoamylase from GM Aspergillus niger as a processing aid) Variation.

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

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

Schedule to the variation

Item [1] of the Schedule to the variation inserts a new entry, in alphabetical order, into column 1 of the table to subsection S18—9(3) of the Code.

The new entry consists of the following enzyme:

‘Glucoamylase, protein engineered variant, (EC 3.2.1.3) sourced from Aspergillus niger containing the glucoamylase gene from Gloeophyllum sepiarium.’

The permitted technological purpose for this enzyme is prescribed in column 2 of the table. i.e. for use as a processing aid in:

  • baking;
  • brewing;
  • the production of distilled alcohol; and
  • starch processing for the production of glucose syrups and other starch hydrolysates.

The permission is subject to the condition, as prescribed in column 3 of the table, that the maximum permitted level or amount of this enzyme that may be present in the food must be consistent with GMP.

The effect of item [1] is to permit the use of the protein engineered variant of the enzyme glucoamylase (EC 3.2.1.3) sourced from genetically modified Aspergillus niger containing the glucoamylase gene from Gloeophyllum sepiarium as a processing aid in accordance with the Code.

The Note after the table to subsection S18—9(3) relates to protein engineered variants of enzymes, which are listed in that table as processing aids permitted to be used for specific technological purposes. The Note explains to the reader that if such an enzyme is used as a processing aid, the resulting food may have as an ingredient a food produced using gene technology, and the requirements relating to foods produced using gene technology in the Code will apply (see Standards 1.2.1 and 1.5.2). The Note then lists the relevant enzymes.

‘Glucoamylase, protein engineered variant’ is already listed in that Note.

 

[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 was enacted to establish a framework for the development and maintenance of food standards and food labelling in Australia and New Zealand, aiming to ensure food safety and consumer protection while facilitating efficient trade. The Act was introduced by the Commonwealth Parliament to address the need for a unified approach to food regulation across both countries, recognising the mutual benefits of harmonised standards. The primary policy objective of the Act is to ensure that food standards are developed through a transparent, science-based process that takes into account public health and safety, economic considerations, and international obligations. The Act facilitates the establishment of an intergovernmental scheme involving the Commonwealth and the states, enabling the development of food standards that are considered and endorsed by the Food Ministers’ Meeting, ultimately leading to their incorporation into national food laws. The Act also gives effect to Australia's obligations under international agreements, ensuring that Australian food standards are consistent with global best practices.

Scope and Application

The Food Standards (Application A1291 – Glucoamylase from GM Aspergillus niger as a processing aid) Variation amends the Australia New Zealand Food Standards Code to permit the use of a protein engineered variant of the enzyme glucoamylase produced by a genetically modified Aspergillus niger containing the glucoamylase gene from Gloeophyllum sepiarium as a processing aid in specific food production processes, including baking, brewing, the production of distilled alcohol, and starch processing to produce glucose syrups and other starch hydrolysates. This variation applies to food manufacturers and processors within Australia and New Zealand, as it becomes part of their respective food laws upon endorsement by the Food Ministers’ Meeting. The variation is subject to the condition that the maximum permitted level or amount of the enzyme must be consistent with good manufacturing practice. The Food Standards Australia New Zealand Act 1991 (FSANZ Act) facilitates the establishment and operation of a national uniform food regulation scheme and gives effect to Australia’s obligations under an international agreement with New Zealand. This instrument is not subject to disallowance or sunsetting provisions as it is considered to be facilitating an intergovernmental scheme and giving effect to an international obligation of Australia.

Key Provisions

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) allows the Authority to develop and vary standards and regulations for food. Under section 13 of the FSANZ Act, the Authority has the power to develop or modify food standards, which includes accepting applications for such changes. For instance, Application A1291 sought to amend the Australia New Zealand Food Standards Code (the Code) to allow the use of a genetically modified enzyme, glucoamylase, as a processing aid in various food production processes. The Authority has approved a draft variation to permit this use, subject to specific conditions. The obligations imposed by the FSANZ Act on the Authority include the requirement to consider applications in line with the procedures outlined in Division 1 of Part 3 of the Act. This includes conducting assessments and undergoing public consultation. In this case, the Authority followed these procedures and held one round of public consultation on the draft variation, inviting submissions between 27 August and 24 September 2024. Furthermore, the Authority must publish a notice about the draft variation, as stipulated by section 92 of the FSANZ Act. The approved draft variation permits the use of a genetically modified glucoamylase enzyme as a processing aid in baking, brewing, distilled alcohol production, and starch processing. However, the use of this enzyme is subject to the condition that its presence in food must align with good manufacturing practice (GMP). This means that the enzyme's maximum permitted levels in food must be consistent with industry standards to ensure safety and quality. Breaches of the provisions in the FSANZ Act or the Food Standards Code could result in various consequences. While the explanatory statement does not specify offences or penalties, it is known that non-compliance with food standards can lead to regulatory action, including fines, recalls, and legal proceedings under both federal and state/territory laws. The maximum penalties for such breaches can vary, often depending on the severity and intent of the violation. These actions are intended to ensure that food products are safe and comply with the standards set by the Authority. The legislative instrument is exempt from disallowance and sunsetting provisions under the Legislation Act 2003, as it facilitates an intergovernmental scheme and gives effect to international obligations. This means that once the variation is endorsed by the Food Ministers’ Meeting and gazetted, it becomes part of the national food laws and is subject to enforcement by relevant authorities.

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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.