Food Standards (Application A1220 – Beta-amylase from GM Bacillus licheniformis as a processing aid) Variation

Administered by Department of Health, Disability and Ageing

Legislation au F2023L00186 Not in force Legislative Instrument

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Explanatory Statement

 

Food Standards Australia New Zealand Act 1991

Food Standards (Application A1220 – Beta-amylase from GM Bacillus licheniformis 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 A1220 which sought to amend the Code to permit the enzyme beta-amylase (β-amylase) from a genetically modified strain of Bacillus licheniformis to be used as a processing aid in starch processing to manufacture maltose syrup. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft variation – the Food Standards (Application A1220 – Beta-amylase from GM Bacillus licheniformis as a processing aid) 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 standard or draft variation of a standard.

 

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 S18––9(3) in Schedule 18 of the Code to permit the use of the enzyme β-amylase (EC 3.2.1.2) sourced from Bacillus licheniformis containing the β-amylase gene from Priestia flexa (basionym Bacillus flexus) as a processing aid in starch processing to manufacture maltose syrup. 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 will 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) Combined Compendium of Food Additive Specifications (FAO JECFA Monographs 23 (2019)) and the United States Pharmacopeial Convention (2020) Food Chemicals Codex (12th edition). These include general specifications for the identity and purity 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 A1220 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 2 August 2022 for a six-week consultation period.

 

The Office of Best Practice Regulation (OBPR) granted the Authority a standing exemption from the requirement to develop a Regulatory Impact Statement for applications relating to permitting new processing aids and genetically modified foods (OBPR correspondence dated 24 November 2010 - reference 12065). This standing exemption was provided as permitting new genetically modified foods and new processing aids 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

 

Item [1] of the Schedule to the variation inserts a new entry, in alphabetical order, into the table to subsection S18—9(3) in Schedule 18. The new entry consists of the following enzyme in column 1 of the table:

 

  • β-Amylase (EC 3.2.1.2) sourced from Bacillus licheniformis containing the β-amylase gene from Priestia flexa (basionym Bacillus flexus).

 

The technological purpose for this enzyme prescribed in column 2 of the table is use as a processing aid in starch processing to manufacture maltose syrup. Specifically, the enzyme catalyses the hydrolysis of starch to maltose.

 

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 the variation is to permit the proposed use of β-amylase (EC 3.2.1.2) sourced from Bacillus licheniformis containing the β-amylase gene from Priestia flexa (basionym Bacillus flexus) as a processing aid in accordance with the Code.

 

 

Overview

The Food Standards Australia New Zealand Act 1991 was enacted to ensure the safety and quality of the food supply by providing a unified system of food regulation across Australia and New Zealand. The Act addresses the need for consistent food standards and regulatory measures by establishing Food Standards Australia New Zealand (FSANZ) as the primary body responsible for developing and managing food standards. The objective of the Act is to facilitate the establishment and operation of an intergovernmental scheme involving the Commonwealth and the States, as well as to give effect to Australia's international obligations under agreements with New Zealand. The Food Standards (Application A1220 – Beta-amylase from GM Bacillus licheniformis as a processing aid) Variation, approved under the Act, permits the use of beta-amylase from a genetically modified Bacillus licheniformis strain as a processing aid in starch processing, subject to conditions ensuring it complies with Good Manufacturing Practice. This legislative instrument was developed following public consultation and is exempt from certain legislative requirements due to its deregulatory nature and alignment with intergovernmental and international agreements.

Scope and Application

The Food Standards (Application A1220 – Beta-amylase from GM Bacillus licheniformis as a processing aid) Variation, a legislative instrument under the Food Standards Australia New Zealand Act 1991, pertains to the approval of the enzyme beta-amylase sourced from a genetically modified strain of Bacillus licheniformis for use as a processing aid in starch processing to manufacture maltose syrup. This variation applies to food manufacturers and processors who use or intend to use this specific enzyme in their food production processes. It is applicable across the Commonwealth, State, and Territory jurisdictions in Australia, and it also affects entities in New Zealand as part of the intergovernmental scheme established under the Food Regulation Agreement and the international agreement between Australia and New Zealand. The variation does not incorporate any documents by reference but relies on existing provisions in the Australia New Zealand Food Standards Code that incorporate documents such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Combined Compendium of Food Additive Specifications. The use of this enzyme is subject to the condition that the maximum permitted level must align with Good Manufacturing Practice (GMP). Notably, the instrument is not subject to disallowance or sunsetting provisions as it facilitates the establishment or operation of an intergovernmental scheme and gives effect to international obligations. The Authority's approval follows a process that includes a round of public consultation, and the instrument is exempt from requiring a Regulatory Impact Statement and a statement of compatibility with human rights.

Key Provisions

The Food Standards Australia New Zealand (FSANZ) Act 1991 (FSANZ Act) enables the Authority to develop and vary food standards, and this variation (F2023L00186) amends the Australia New Zealand Food Standards Code (Code) to allow the use of the enzyme beta-amylase from a genetically modified Bacillus licheniformis strain as a processing aid in starch processing to manufacture maltose syrup (section 13). The Authority's consideration of this application (Application A1220) followed the stipulated procedure under Division 1 of Part 3 of the FSANZ Act, which includes a public consultation phase (section 92). The approved draft variation is a legislative instrument (section 94) and is publicly available on the Federal Register of Legislation, with a note that it is exempt from disallowance and sunsetting provisions (Legislation Act 2003, sections 44(1) and 54(1)). The variation imposes several obligations and requirements on the parties it governs. The Authority, as the governing body, must ensure that any permitted use of the beta-amylase enzyme adheres to Good Manufacturing Practice (GMP) as specified in the Code (subsection S18–9(3) in Schedule 18). This means that any food containing this enzyme must comply with the established purity and identity specifications outlined in relevant schedules of the Code, which incorporate by reference documents such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Combined Compendium of Food Additive Specifications and the United States Pharmacopeial Convention (USP) Food Chemicals Codex. These documents prescribe the necessary identity and purity standards for enzyme preparations used in food processing (section 1.1.1–15 and S3–2 of Schedule 3). The FSANZ Act does not explicitly detail specific offences, penalties, or consequences for breach in this context. However, the general framework under which the Authority operates implies that any non-compliance with the stipulated standards and conditions could lead to regulatory action. The FSANZ Act and the associated Code are part of a broader regulatory scheme that involves Commonwealth, State, Territory, and New Zealand regulators. These regulators have the authority to enforce the standards and take appropriate action against entities that fail to comply, which may include fines, recalls, or other enforcement measures. While specific penalties are not detailed in this explanatory statement, the overarching legislative intent is to ensure food safety and consumer protection by enforcing compliance with the standards set forth in the Code. In summary, the Food Standards (Application A1220 – Beta-amylase from GM Bacillus licheniformis as a processing aid) Variation introduces a legislative amendment that allows the use of a genetically modified enzyme as a processing aid in food production, subject to certain conditions. The variation imposes obligations on the Authority to ensure compliance with GMP and adherence to specified purity and identity standards. While the explanatory statement does not detail specific penalties, non-compliance with the Code could result in enforcement actions by relevant regulators.

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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.