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 A1182 which seeks to permit the use of glucose oxidase enzyme preparation from a particular GM T. reesei as a processing aid for use in the manufacture and processing of specified foods. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft Standard.
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 to permit the use of glucose oxidase enzyme preparation from a particular GM T. reesei as a processing aid. The permission will be listed in the table to subsection S18—9(3), which includes enzymes permitted for a specific technological purpose. The technological purpose in this case is for use in the manufacture of bakery and other cereal-based products such as pasta and noodles, and for use in egg processing. The level of usage is an amount consistent with GMP. This permission requires varying the table to subsection S18—9(3) in Schedule 18.
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 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 Compendium of Food Additive Specifications (FAO/WHO 2017) and the United States Pharmacopeial Convention (USPC 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 A1182 included one round of public consultation following an assessment and the preparation of a draft Standard and associated assessment summary. Submissions were called for on 21 November 2019 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) in Schedule 18.
The new entry would permit the use of the enzyme, glucose oxidase (EC 1.1.3.4) sourced from a particular GM T. reesei (T. reesei containing the glucose oxidase gene from P. amagasakiense), as a processing aid in food for a specific technological purpose.
The technological purpose is for use as a processing aid in the manufacture of bakery and other cereal-based products, and in egg processing.
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.