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 A1185 which seeks permission to use the enzyme alpha-amylase (EC 3.2.1.1) from a genetically modified (GM) strain of Aspergillus niger (A. niger) as a processing aid in starch processing and the production of potable alcohol. 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 alpha-amylase (EC 3.2.1.1), sourced from A. niger containing the alpha-amylase gene from Rhizomucor pusillus (R. pusillus), as a processing aid in starch processing 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 A1185 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 11 February 2020 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
The variation inserts a new entry, in alphabetical order, into the table to subsection S18—9(3) of the Code.
The new entry consists of the enzyme ‘α-Amylase (EC 3.2.1.1), sourced from Aspergillus niger containing the α-Amylase gene from Rhizomucor pusillus’, for use as a processing aid in food for specific technological purposes.
The technological purposes for this enzyme are ‘For use in starch processing 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) was enacted to provide a legislative framework for the development of food standards by Food Standards Australia New Zealand (FSANZ), ensuring food safety and public health protection in Australia and New Zealand. This Act addresses the need for a unified approach to food regulation across the two countries. The FSANZ Act grants the Authority the power to develop food standards and variations of standards, as well as to accept and consider applications for such developments or variations. This legislative instrument is a response to Application A1185, which seeks permission to use the enzyme alpha-amylase from a genetically modified strain of Aspergillus niger as a processing aid in starch processing and the production of potable alcohol. Following the consideration of this application, the Authority approved a draft variation that allows for the use of this enzyme under certain conditions, subject to the maximum permitted level being consistent with good manufacturing practice. The legislative process involved public consultation, and the instrument was exempt from the need for a Regulatory Impact Statement due to its minor impact on business and individuals. This legislative instrument is a minor, deregulatory change that permits the introduction of a food product determined to be safe into the food supply, and the use of the processing aid remains voluntary.
Scope and Application
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) empowers Food Standards Australia New Zealand (FSANZ) to develop standards and variations of standards for the Australia New Zealand Food Standards Code (Code). This legislation applies to FSANZ, the food industry, and any entities or individuals involved in the production, processing, and sale of food products within Australia and New Zealand. The Act facilitates the consideration and acceptance of applications for the development or variation of food regulatory measures, including standards, following a specified procedure. In this instance, the Authority has approved a draft variation allowing the use of the enzyme alpha-amylase, derived from a genetically modified strain of Aspergillus niger, as a processing aid in starch processing and the production of potable alcohol. The draft variation will be published following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation, as per section 92 of the FSANZ Act. The approved variation is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003. The Authority conducted one round of public consultation as part of its consideration of the application, in accordance with the procedure outlined in Division 1 of Part 3 of the FSANZ Act. The exemption from developing a Regulatory Impact Statement, granted by the Office of Best Practice Regulation, recognises that permitting additional processing aids is likely to have only a minor impact on business and individuals. The variation allows for the voluntary use of the approved processing aid in food for specific technological purposes, subject to the condition that its use must be consistent with good manufacturing practice.
Key Provisions
The primary sections of this legislation involve the approval and publication of a draft variation to the Australia New Zealand Food Standards Code (the Code) by Food Standards Australia New Zealand (the Authority) (section 13). Section 92 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) mandates that the Authority publish a notice regarding the standard or draft variation of a standard, while section 94 specifies that such a standard or variation is a legislative instrument, but not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003. The Authority has approved a draft variation to permit the use of the enzyme alpha-amylase (EC 3.2.1.1), sourced from Aspergillus niger containing the alpha-amylase gene from Rhizomucor pusillus (R. pusillus), as a processing aid in starch processing and the production of potable alcohol (section 2).
The obligations imposed by this legislation include the Authority’s duty to accept applications for the development or variation of food regulatory measures, including standards, and to consider such applications in accordance with Division 1 of Part 3 of the FSANZ Act. The Authority must also undertake a round of public consultation on the draft variation and associated assessment summary. This process was followed with Application A1185, which sought permission to use the enzyme alpha-amylase from a genetically modified (GM) strain of Aspergillus niger as a processing aid in starch processing and the production of potable alcohol. Additionally, the Authority must publish a notice regarding the draft variation, as stipulated by section 92 of the FSANZ Act.
In terms of offences, penalties, or consequences for breach, this legislation does not specify any particular criminal or civil penalties for non-compliance with the approved draft variation. However, it is implied that adherence to the approved conditions for the use of the enzyme alpha-amylase as a processing aid is mandatory. The maximum permitted level or amount of this enzyme that may be present in the food must be consistent with good manufacturing practice, ensuring that any use of the enzyme complies with safety and quality standards.
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. The exemption from needing to develop a Regulatory Impact Statement was granted by the Office of Best Practice Regulation (OBPR) due to the minor impact on business and individuals. The Authority’s consideration of Application A1185 involved one round of public consultation for a six-week period, as per the procedure outlined in Division 1 of Part 3 of the FSANZ Act.