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 A1211 which sought an amendment to the Code to permit a new source microorganism, being a genetically modified Bacillus licheniformis, for the permitted enzyme, maltogenic alpha-amylase. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation.
Following consideration by the Food Ministers’ Meeting[1], section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the standard or draft variation of a standard.
Section 94 of the FSANZ Act specifies that a standard, or a variation of a standard, in relation to which a notice is published under section 92 is a legislative instrument, but is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003.
2. Purpose
The Authority has approved a draft variation amending the table to section S18––9(3) of the Code to permit the use of maltogenic alpha-amylase (EC 3.2.1.133) sourced from Bacillus licheniformis containing the maltogenic alpha-amylase gene from Geobacillus stearothermophilus as a processing aid for use in brewing, manufacture of bakery products, the production of potable alcohol and starch processing.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
Existing provisions of the Code incorporate a document by reference that will prescribe identity and purity specifications for the processing aid to be permitted by the 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 2017) and the United States Pharmacopeial Convention (2018) Food Chemicals Codex (11th edition). These include specifications for enzyme preparations used in food processing.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of application A1211 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 27 July 2021 for a six-week consultation period.
The Office of Best Practice Regulation (OBPR) granted the Authority a standing exemption from needing to develop a Regulatory Impact Statement for proposed variations of the Code to permit additional processing aids (OBPR correspondence dated 24 November 2010 - reference 12065). This standing exemption was provided as permitting additional processing aids is likely to have only a minor impact on business and individuals. It is a minor, deregulatory change that allows for the introduction of a food product to the food supply that has been determined to be safe. The use of the approved processing aid is also voluntary.
5. 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 94 of the FSANZ Act.
6. Variation
Item [1] of the Schedule to the variation inserts a new entry into the table to subsection S18—9(3) in Schedule 18 of the Code.
The new entry permits the use as a processing aid of maltogenic alpha-amylase (EC 3.2.1.133) sourced from Bacillus licheniformis containing the maltogenic alpha-amylase gene from Geobacillus stearothermophilus. The permission limits its use as a processing aid in brewing, the manufacture of bakery products, the production of potable alcohol and starch processing. A condition of the permission is that the maximum permitted level or amount that may be used must be consistent with Good Manufacturing Practice (GMP).
[1] Formerly the Australia and New Zealand Ministerial Forum on Food Regulation.
Overview
The Food Standards Australia New Zealand Amendment (2022 Measures) Instrument 2022 (F2022L00039) was enacted to address the need for updating the Australia New Zealand Food Standards Code by permitting a new source microorganism for a specific enzyme. This legislative instrument amends the Code to allow the use of maltogenic alpha-amylase sourced from a genetically modified Bacillus licheniformis, which contains the maltogenic alpha-amylase gene from Geobacillus stearothermophilus, as a processing aid in various food production processes, including brewing, bakery manufacturing, and starch processing. This change was approved following a review of an application under the Food Standards Australia New Zealand Act 1991, which mandates the development and variation of food standards. The instrument was developed in compliance with the legislative framework that requires public consultation and does not necessitate a Regulatory Impact Statement, given its minor regulatory impact. The instrument was introduced and passed by the Australian Parliament, reflecting a policy objective to facilitate the safe and voluntary introduction of new processing aids in the food supply.
Scope and Application
The legislation F2022L00039 pertains to a variation of the Australia New Zealand Food Standards Code, which is overseen by Food Standards Australia New Zealand (FSANZ) under the Food Standards Australia New Zealand Act 1991. The variation approved by the Authority involves amending the Code to permit the use of a genetically modified Bacillus licheniformis, specifically the maltogenic alpha-amylase gene from Geobacillus stearothermophilus, as a processing aid for various food industries. This includes its use in brewing, the manufacture of bakery products, the production of potable alcohol, and starch processing. The application of this variation is governed by the FSANZ Act, and it applies to entities and industries within the food sector that engage in these specified processes. The jurisdictional reach of this legislation is both Commonwealth and state, as it pertains to the Australia New Zealand Food Standards Code which is administered at a federal level but applies across all states and territories in Australia. Exemptions from certain regulatory processes, such as the requirement to develop a Regulatory Impact Statement, have been granted given the minimal impact of this minor, deregulatory change. The legislation is exempt from requiring a statement of compatibility with human rights due to its classification as a non-disallowable instrument. This variation does not incorporate any documents by reference but refers to existing provisions within the Code that include specifications for identity and purity.
Key Provisions
The main operative sections of the legislation revolve around the approval and implementation of a variation to the Australia New Zealand Food Standards Code, specifically allowing the use of a new source microorganism for the enzyme maltogenic alpha-amylase. Section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) empowers the Authority to develop standards and variations of standards for the Code. Division 1 of Part 3 of the FSANZ Act outlines the procedure for considering applications for the development or variation of food regulatory measures. Following the acceptance and consideration of application A1211, the Authority has approved a draft variation that permits a genetically modified Bacillus licheniformis as a source for the enzyme maltogenic alpha-amylase (EC 3.2.1.133) in specified food processes.
The obligations imposed by the Act on the parties or entities it governs primarily focus on compliance with the new standards set forth in the Code. The Authority is required to publish a notice regarding the draft variation under section 92 of the FSANZ Act. Additionally, the Code itself mandates that substances used as processing aids, such as the approved enzyme, must comply with relevant identity and purity specifications. These specifications are detailed in Schedule 3 of the Code, which incorporates by reference the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications and the United States Pharmacopeial Convention (USP) Food Chemicals Codex.
The legislation does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches related to this variation. However, general provisions under the FSANZ Act likely imply that non-compliance with the standards or failure to adhere to the permitted conditions could result in regulatory actions. Such actions might include enforcement measures by regulatory authorities, which could range from warnings and fines to more stringent regulatory actions if the breach is deemed significant. Although the exact penalties are not detailed in the provided text, they would typically be consistent with other regulatory frameworks governing food safety and standards in Australia.