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 A1231 which sought permission to use the enzyme maltogenic alpha amylase (EC 3.2.1.133) sourced from a genetically modified (GM) strain of Escherichia coli (E. coli), expressing a maltogenic alpha amylase gene from Geobacillus stearothermophilus , as a processing aid in baking, brewing and starch processing. 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 the enzyme, maltogenic alpha amylase (EC 3.2.1.133) sourced from a GM strain of E. coli expressing a maltogenic alpha amylase gene from Geobacillus stearothermophilus, as a processing aid in baking, brewing and starch processing, subject to the condition that the amount of enzyme used must be consistent with good manufacturing practice (GMP).
The Authority noted that the International Union of Biochemistry and Molecular Biology uses the ‘accepted’ name ‘glucan 1,4-α-maltohydrolase’ for this enzyme. However, the Authority decided to use the alternative name ‘maltogenic α-amylase’ in the variation to the Code, to remain consistent with how the already permitted maltogenic alpha amylases have been listed in the Code. A variation of this name i.e. ‘maltogenic alpha amylase’ was used throughout the application and, as such, this document.
3. 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. 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/WHO 2019) and the United States Pharmacopeial Convention (2020) Food Chemicals Codex (12th 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 A1231 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 30 November 2021 for a seven-week consultation period.
The Office of Best Practice Regulation (OBPR) granted the Authority a standing exemption from the requirement to develop a Regulatory Impact Statement (RIS) for applications relating to processing aids and genetically modified food (OBPR correspondence dated 24 November 2010, reference 12065). This standing exemption was provided as permitting new genetically modified foods and new processing aids is deregulatory as their use will be voluntary if the application is approved. This standing exemption relates to the introduction of a food 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 inserts in the table to subsection S18—9(3) a new entry for “Maltogenic α-Amylase (EC 3.2.1.133) sourced from Escherichia coli containing the maltogenic α-Amylase gene from Geobacillus stearothermophilus” into column 1, and “For use in baking, brewing and starch processing” into column 2, and “GMP” into column 3.
The new entry, in effect, permits the use of the enzyme, maltogenic alpha amylase (EC number 3.2.1.133), sourced from E. coli containing the maltogenic alpha amylase gene from G. stearothermophilus, as a processing aid for a specific technological purpose. The permitted technological purpose for this enzyme is use as a processing aid in baking, brewing and starch processing.
The permission is subject to the condition that the maximum permitted level or amount of this enzyme that may be used in food processing must be consistent with GMP.
[1] Formerly referred to as the Australia and New Zealand Ministerial Forum on Food Regulation.