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).