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 A1210 which sought an amendment of the Code to permit the use of the enzyme, maltogenic alpha-amylase (EC 3.2.1.133) derived from a genetically modified (GM) strain of Saccharomyces cerevisiae (S. cerevisiae), containing the maltogenic alpha-amylase gene from Geobacillus stearothermophilus,(G. stearothermophilus) as a processing aid for use in manufacture of bakery products. This maltogenic alpha-amylase enzyme is described as being protein engineered. 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, protein engineered variant, (EC 3.2.1.133) derived from GM S. cerevisiae containing the maltogenic alpha-amylase gene from G. stearothermophilus, as a processing aid for use in the manufacture of bakery products.
3. Documents incorporated by reference
The variation in this instrument does 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 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 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 A1210 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 January 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
Sub-item [1.1] of the Schedule to the variation inserts a new entry, in alphabetical order, 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 Saccharomyces cerevisiae containing the maltogenic alpha-amylase gene from Geobacillus stearothermophilus. The permission limits its use as a processing aid to the manufacture of bakery products. A condition of the permission is that the maximum permitted level or amount that may be used must be consistent with good manufacturing practice.
Sub-item [1.2] of the Schedule to the variation inserts a new note below the table to subsection S18—9(3). The purpose of the new note is to highlight that some enzymes listed in that table are protein engineered and that the requirements listed in Standard 1.2.1 and Standard 1.5.2 relating to foods produced using gene technology may apply to their use.
[1] Formerly the Australia and New Zealand Ministerial Forum on Food Regulation. The Forum name change took effect on 21 February 2021 following a decision by Ministers.