Explanatory Statement
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 A1195 which seeks permission to use a new microbial source of the already permitted enzyme processing aid, alpha-amylase (α-Amylase) (EC 3.2.1.1) for use in brewing and the production of potable alcohol. For Application A1195, the enzyme is derived from a genetically modified (GM) strain of Trichoderma reesei expressing the α-Amylase gene from Aspergillus kawachii. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation.
Following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation, 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 subsection S18––9(3) of the Code to permit the use of the enzyme, α-Amylase (EC 3.2.1.1) sourced from Trichoderma reesei containing the α-Amylase gene from Aspergillus kawachii, as a processing aid in brewing and the production of potable alcohol.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of application A1195 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 June 2020 for a six-week consultation period.
The Office of Best Practice Regulation (OBPR) granted FSANZ a standing exemption from the requirement to develop a Regulatory Impact Statement for permitting the use of new processing aids (OBPR correspondence dated 24 November 2010, reference number 12065). This standing exemption was provided as permitting new processing aids is machinery in nature and the use of the new processing aid is voluntary once the application has been successfully approved. This standing exemption relates to the introduction of a processing aid to the food supply that has been determined to be safe.
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 variation amends Schedule 18 of the Code by inserting a new entry, in alphabetical order, into the table to subsection S18—9(3).
The new entry consists of the enzyme ‘α-Amylase (EC 3.2.1.1) sourced from Trichoderma reesei containing the α-Amylase gene from Aspergillus kawachii’, for use as a processing aid in food for specific technological purposes.
The technological purposes for this enzyme are ‘For use in brewing and the production of potable alcohol’.
The permission is 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 manufacturing practice.
The variation refers to ‘α-Amylase’ which is the accepted name used by the International Union of Biochemistry and Molecular Biology (IUBMB) for the enzyme with EC number 3.2.1.1 (IUBMB 2017).
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) is a legislative framework governing the establishment and operation of Food Standards Australia New Zealand (FSANZ), the binational agency responsible for developing food standards for Australia and New Zealand. The Act was enacted to address the need for a coordinated approach to food regulation across both countries, ensuring food safety and public health while facilitating trade. The problem it sought to address was the fragmented and inconsistent food regulation that existed prior to the establishment of FSANZ, which led to inefficiencies and potential health risks. The FSANZ Act was enacted by the Commonwealth Parliament of Australia and outlines the policy objective of ensuring a consistent, science-based approach to food regulation.
In light of this legislative foundation, the Authority, under the FSANZ Act, has the mandate to accept applications for the development or variation of food regulatory measures, including standards. The Authority has approved a draft variation for a new microbial source of the enzyme alpha-amylase, derived from a genetically modified strain of Trichoderma reesei expressing the α-Amylase gene from Aspergillus kawachii, to be used as a processing aid in brewing and the production of potable alcohol. This approval follows a round of public consultation and aligns with the FSANZ Act's mandate to ensure the safety and quality of the food supply while adapting to new technologies.
Scope and Application
The Food Standards Australia New Zealand Act 1991 authorises Food Standards Australia New Zealand (FSANZ) to develop, amend, and vary food standards within the Australia New Zealand Food Standards Code. The Act applies to FSANZ and the entities subject to its regulatory measures, including food manufacturers and producers operating within Australia and New Zealand. The geographic reach of the Act encompasses both countries, ensuring uniform food standards across the region. The legislation outlines procedures for considering applications to develop or vary food regulatory measures, such as the approval of a new microbial source for an enzyme processing aid in brewing and potable alcohol production. While the Act itself sets the framework for food standards, subordinate instruments may extend or restrict application by detailing specific requirements and conditions. The legislative instrument resulting from the approval of Application A1195 is not subject to disallowance or sunsetting under the Legislation Act 2003, but it is subject to the condition that the maximum permitted level of the enzyme must align with good manufacturing practice.
Key Provisions
The main operative sections of this legislation concern the approval and publication of a draft variation to the Australia New Zealand Food Standards Code (the Code) allowing for the use of a new microbial source of the enzyme alpha-amylase in brewing and the production of potable alcohol (section 2). This amendment is made under the authority granted to Food Standards Australia New Zealand (the Authority) by the Food Standards Australia New Zealand Act 1991 (the FSANZ Act). Specifically, section 13 of the FSANZ Act allows the Authority to develop standards and variations of standards for inclusion in the Code, while section 92 requires the Authority to publish a notice about the standard or draft variation of a standard. Once considered by the Australia and New Zealand Ministerial Forum on Food Regulation, the draft variation becomes a legislative instrument under section 94 of the FSANZ Act, although it is not subject to parliamentary disallowance or sunsetting.
The obligations imposed by this legislation primarily pertain to the Authority, which must follow the procedures outlined in Division 1 of Part 3 of the FSANZ Act when considering applications for the development or variation of food regulatory measures. This includes conducting a round of public consultation, as specified in the explanatory statement. The Authority is also required to publish a notice about the draft variation, ensuring that stakeholders are informed of the proposed changes. Additionally, the Authority must ensure that any new processing aids introduced under this variation are consistent with good manufacturing practices and are safe for use in the food supply.
There are no explicit offences or penalties detailed in the explanatory statement for the breach of the provisions in this legislation. However, the FSANZ Act and related legislation may impose various civil or criminal consequences for non-compliance with food safety standards and regulations. For example, breaches of the Food Standards Code can result in enforcement actions such as fines, court proceedings, or other regulatory measures. The maximum penalties for such breaches can vary widely depending on the specific circumstances and the applicable legislation but may include significant fines for corporations and potential imprisonment for individuals found guilty of serious offences.
This legislation does not incorporate any documents by reference (section 4), and the Authority has been granted a standing exemption from the requirement to develop a Regulatory Impact Statement for permitting the use of new processing aids (section 4). The exemption was granted by the Office of Best Practice Regulation as the use of new processing aids is considered machinery in nature and voluntary once approved. Furthermore, 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 (section 5).