Draft 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 A1206 which seeks to permit the use of subtilisin (EC 3.4.21.62) from a genetically modified strain of Bacillus licheniformis (B. licheniformis) containing the subtilisin gene from Pyrococcus furiosus, as a processing aid in the production of potable alcohol. 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 subsection S18––9(3) of the Code to permit the use of the enzyme subtilisin (EC 3.4.21.62) sourced from B. licheniformis containing the gene for subtilisin from Pyrococcus furiosus, as a processing aid in the production of potable alcohol.
3. Documents incorporated by reference
The variation in this instrument does not incorporate any documents by reference.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1206 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 3 December 2020 for an eight-week consultation period.
The Office of Best Practice Regulation (OBPR) granted FSANZ a standing exemption from the requirement to develop a Regulatory Impact Statement (RIS) for permitting genetically modified foods and the voluntary addition of processing aids to foods (OBPR correspondence dated 24 November 2010, reference 12065). This standing exemption was provided as permitting new GM foods and new enzyme 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] inserts a new entry, in alphabetical order, into the table to subsection S18—9(3) of the Code.
The new entry consists of the enzyme subtilisin (EC 3.4.21.62) sourced from Bacillus licheniformis containing the gene for subtilisin from Pyrococcus furiosus, as a processing aid in food for a specific technological purpose.
The technological purpose is for use in the production of potable alcohol.
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.
1 Formerly referred to as the Australia and New Zealand Ministerial Forum on Food Regulation.