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 A1171 which seeks permission to use the enzyme endo-inulinase (EC 3.2.1.7) from a genetically modified (GM) strain of Aspergillus oryzae (A. oryzae) as a processing aid in the hydrolysis of inulin to produce fructo-oligosaccharides (FOS). The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft Standard.
The Authority noted that the IUBMB uses the ‘accepted’ name ‘inulinase’ for this enzyme (IUBMB 2017). ‘Other’ names for this enzyme include ‘endo-inulinase’, which is the name used throughout the application, this document, and Supporting Document 1. However, the accepted name ‘inulinase’ is the name that has been used in the variation to the Code for this enzyme
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 variation to amend the table to subsection S18––9(3) in Schedule 18 of the Code to permit the use of the enzyme endo-inulinase (EC 3.2.1.7) from a GM strain of A. oryzae as a processing aid in hydrolysing inulin to produce FOS.
3. Documents incorporated by reference
The variations to food regulatory measures do 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 to be permitted by the 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 A1171 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 5 September for a six-week consultation period.
The Office of Best Practice Regulation (OBPR) granted FSANZ 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
Item [1] of the variation inserts in the table to subsection S18—9(3) in Schedule 18 in alphabetical order, a new entry for “Inulinase (EC 3.2.1.7) sourced from Aspergillus oryzae containing the inulinase gene from Aspergillus ficuum” into column 1, and “Hydrolysing inulin to produce fructo-oligosaccharides” into column 2, and “GMP” into column 3.
The new entry will, in effect, permit the enzyme endo-inulinase (EC number 3.2.1.7), derived from the GM strain of A. oryzae, to be used as a processing aid in food, with a technological purpose of hydrolysing inulin to produce FOS, with the condition that the amount used must be consistent with good manufacturing practice (GMP).