Federal Register of Legislation - Australian Government

Primary content

Food Standards as made
This instrument varies standards in the Australia New Zealand Food Standards Code.
Administered by: Health
Exempt from sunsetting by the Legislation Act 2003 s 54(1)
Registered 04 Dec 2019
Tabling HistoryDate
Tabled HR05-Dec-2019
Tabled Senate04-Feb-2020
Date of repeal 06 Dec 2019
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

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 A1164 which seeks permission to use the enzyme pullulanase (EC from a genetically modified (GM) strain of Bacillus licheniformis as a processing aid in brewing and starch processing. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation to the Code.


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.  


2.       Purpose


The Authority has approved an amendment to the table to section S18––9(3) in Schedule 18 of the Code to permit the use of the enzyme pullulanase (EC from a GM strain of B. licheniformis as a processing aid in brewing and starch processing.


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 (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 A1164 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 6 June 2019 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 “Pullulanase (EC sourced from Bacillus licheniformis containing the pullulanase gene from Bacillus deramificans” into column 1, and “For use in brewing and in starch processing” into column 2, and “GMP” into column 3.


The new entry will, in effect, permit pullulanase (EC number, derived from the GM strain of B. licheniformis, to be used as a processing aid in food, with a technological purpose of brewing and starch processing, with the condition that the amount used must be consistent with good manufacturing practice (GMP).