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 A1131 which seeks to permit the use of the enzyme aqualysin 1 sourced from Bacillus subtilis containing the aqualysin 1 gene from Thermus aquaticus as a processing aid for use in the manufacture of bakery products. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft variation.
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 Code does not currently permit the use of the enzyme aqualysin 1 sourced from Bacillus subtilis containing the aqualysin 1 gene from Thermus aquaticus as a processing aid. The purpose of this variation is to permit the use of this enzyme as a processing aid only in the manufacture of bakery products, at GMP.
3. Documents incorporated by reference
The variations to food regulatory measures do 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 A1131 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 20 July 2017 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variation to Schedule 18 was likely to have a minor impact on business and individuals.
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 into the table to subsection S18—9(3) in Schedule 18 of the Code. The name of the enzyme in the table is aqualysin 1 which has the Enzyme Commission (EC) number 3.4.21.111. The source microorganism is Bacillus subtilis containing the aqualysin 1 gene from Thermus aquaticus. The prescribed technological purpose is for use in the manufacture of bakery products. The maximum permitted level is GMP.