Food Standards (Application A1245 – Alpha-glucosidase from GM Trichoderma reesei as a processing aid in brewing) Variation

Administered by Department of Health, Disability and Ageing

Legislation au F2023L01402 Not in force Legislative Instrument

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EXPLANATORY STATEMENT 

 

Food Standards Australia New Zealand Act 1991 

 

Food Standards (Application A1245 – Alpha-glucosidase from GM Trichoderma reesei as a processing aid in brewing) 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 A1245 which sought to amend the Code to permit an additional use of the enzyme alpha-glucosidase (α-glucosidase) from a genetically modified (GM) strain of Trichoderma reesei containing the α-glucosidase gene from Aspergillus niger as a processing aid in brewing of beer. The Code currently permits this enzyme to be used as a processing aid in the manufacture and/or processing of certain foods but not including beer, subject to the condition that the maximum permitted level or amount of this enzyme that may be present in the food must be consistent with good manufacture practice (GMP). The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation – the Food Standards (Application A1245 – Alpha-glucosidase from GM Trichoderma reesei as a processing aid in brewing) 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 standard or 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 S18––9(3) in Schedule 18 of the Code to permit the use of the enzyme α-glucosidase (EC 3.2.1.20) sourced from a GM strain of Trichoderma reesei containing the α‑glucosidase gene from Aspergillus niger as a processing aid in the manufacture and/or processing of beer. This permission is subject to the existing condition that the maximum permitted level or amount of this enzyme that may be present in the food must be consistent with 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 Food Chemicals Codex (12th edition, 2020). 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 A1245 included one round of public consultation following an assessment and the preparation of a draft variation and associated assessment summary. Submissions were called for on 9 March 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 applications relating to permitting processing aids and GM foods (OBPR correspondence dated 24 November 2010, reference 12065). This standing exemption was provided as permitting processing aids and 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 A1245 – Alpha-glucosidase from GM Trichoderma reesei as a processing aid in brewing) 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 the table item dealing with ‘α-Glucosidase (EC 3.2.1.20) sourced from Trichoderma reesei containing the α‑glucosidase gene from Aspergillus niger’ (the enzyme) in the table to subsection S18—9(3) of the Code by:

  • repealing existing paragraph (e) in the column headed ‘Technological purpose and food’ in relation to that table item; and
  • substituting existing paragraph (e) with a new paragraph (e) with ‘; and’ at the end of it, followed by new paragraph (f) listing ‘beer’ as a food.

 

Paragraph (e) is currently the final listing of food in which the enzyme may be used as a processing aid and, as such, the paragraph has a full stop at the end of it. Therefore, paragraph (e) needs to be repealed and substituted with the new paragraph (e) for the purposes of adding ‘beer’ to the existing list.

The permission to use the enzyme as a processing aid in the manufacture and/or processing of beer is subject to the existing condition 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 the enzyme, α-glucosidase (EC 3.2.1.20) sourced from Trichoderma reesei containing the α‑glucosidase gene from Aspergillus niger, as a processing aid in the manufacture and/or processing of beer 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 (FSANZ Act) was enacted to provide a framework for the development and enforcement of food standards in Australia and New Zealand, facilitating a uniform approach to food regulation across both countries. This legislation establishes Food Standards Australia New Zealand (FSANZ) as the central authority responsible for developing food standards and variations to those standards, which are subject to endorsement by the Food Ministers’ Meeting. The Act addresses the need for consistent food regulatory measures to ensure consumer safety and protection across jurisdictions. The problem it was introduced to address includes the need for a coordinated and efficient system to manage food standards that reflect contemporary food production and technological advancements. Enacted by the Parliament of Australia, the policy objective of the FSANZ Act is to ensure the safety and quality of the food supply, protect public health, and facilitate trade by maintaining a single set of food standards for both Australia and New Zealand.

Scope and Application

The Food Standards (Application A1245 – Alpha-glucosidase from GM Trichoderma reesei as a processing aid in brewing) Variation is a legislative instrument under the Food Standards Australia New Zealand Act 1991, which facilitates the establishment and operation of an intergovernmental scheme for national uniform food regulation involving the Commonwealth, states, and territories, as well as giving effect to Australia’s international obligations with New Zealand. This instrument, approved by Food Standards Australia New Zealand and endorsed by the Food Ministers’ Meeting, amends the Australia New Zealand Food Standards Code to permit the use of a genetically modified enzyme, alpha-glucosidase from Trichoderma reesei, as a processing aid in beer brewing. This amendment subjects the use of the enzyme to existing conditions that its presence in food must align with good manufacturing practices. The variation is not subject to disallowance or sunsetting provisions and applies across the Commonwealth, states, and territories, as well as New Zealand, where it becomes part of their respective food laws. The variation is effective from the date of its gazettal and does not incorporate any documents by reference, although existing provisions of the Code do. Public consultation was conducted as part of the consideration process, and the instrument is exempt from certain regulatory impact assessments and statements of compatibility with human rights.

Key Provisions

The Food Standards (Application A1245 – Alpha-glucosidase from GM Trichoderma reesei as a processing aid in brewing) Variation, as an instrument under the Food Standards Australia New Zealand Act 1991 (the FSANZ Act), introduces a significant change to the Australia New Zealand Food Standards Code (the Code). This change permits the use of alpha-glucosidase (α-glucosidase) sourced from a genetically modified (GM) strain of Trichoderma reesei containing the α-glucosidase gene from Aspergillus niger as a processing aid in the brewing of beer (section 1). This amendment modifies the existing provision in the Code that allows the use of this enzyme in certain foods but excludes beer (section 2). The variation specifies that beer is now included as a permissible food for the use of this enzyme, subject to the condition that the maximum permitted level or amount of the enzyme in the food must align with good manufacture practice (GMP) (section 3). This variation was developed following the acceptance of Application A1245 by the Authority and subsequent endorsement by the Food Ministers’ Meeting (FMM) (section 1). The FSANZ Act imposes specific obligations on the Authority and other entities involved in the food regulatory process. The Authority, as per section 13 of the FSANZ Act, is responsible for developing and varying food regulatory measures, including standards, within the Code. It must consider applications for variations in accordance with the stipulated procedure in Division 1 of Part 3 of the FSANZ Act (section 1). The Authority is also required to publish a notice about the approved draft standard or variation, as stipulated in section 92 of the FSANZ Act (section 1). The Authority’s consideration of the application included a round of public consultation, ensuring transparency and public participation in the regulatory process (section 5). Failure to comply with the provisions of the FSANZ Act or the approved draft variation can lead to various legal consequences. While the specific offences and penalties are not detailed in the explanatory statement, the FSANZ Act generally provides for enforcement mechanisms to ensure compliance with food standards and regulations. The legislative instrument itself is not subject to disallowance or sunsetting provisions, as outlined in sections 44 and 54 of the Legislation Act 2003, because it facilitates an intergovernmental scheme and gives effect to international obligations (section 2). The variation does not incorporate any documents by reference but relies on existing provisions of the Code that incorporate documents by reference for identity and purity specifications (section 4). The Authority has a standing exemption from the requirement to develop a Regulatory Impact Statement for applications relating to permitting processing aids and GM foods, as these are considered deregulatory measures (section 5). In summary, the Food Standards (Application A1245 – Alpha-glucosidase from GM Trichoderma reesei as a processing aid in brewing) Variation introduces a legislative change to permit the use of a specific enzyme as a processing aid in beer brewing, subject to GMP conditions. The FSANZ Act governs the obligations of the Authority and the procedure for considering such applications, while the legislative instrument itself is designed to facilitate national and international food regulation. Compliance with the Act and the approved variation is crucial, and although specific penalties are not detailed in the explanatory statement, the Act provides for enforcement mechanisms to ensure adherence to food standards.

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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.