Explanatory Statement
- 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.
FSANZ accepted Application A1146, which sought an amendment to the Code to permit the use of thermolysin from Anoxybacillus caldiproteolyticus (A. caldiproteolyticus) strain TP-7 as a processing aid in protein, dairy, egg, meat and fish processing and flavour production. The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared 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 draft variation of a standard.
Section 94 of the FSANZ Act specifies that 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 purpose of this legislative instrument is to amend the Code to permit the use of the enzyme, thermolysin (EC 3.4.24.27) sourced from A. caldiproteolyticus strain TP-7 as a processing aid to catalyse the hydrolysis of peptide bonds during the manufacture and/or processing of foods such as: dairy, egg, meat, fish, protein, yeast, and flavouring. This requires an addition to 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.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1146 included one round of public consultation followed by an assessment and the preparation of a draft variation and associated assessment summary.
The Office of Best Practice Regulation (OBPR) granted FSANZ a standing exemption from needing to develop a Regulatory Impact Statement for the approval of additional processing aids, in a letter dated 24 November 2010 (reference 12065). This standing exemption was provided as permitting additional processing aids is a minor, deregulatory change and their use is voluntary. 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] of the variation inserts a new entry into the table to subsection S18—9(3) in Schedule 18.
The new entry will, in effect, permit the enzyme, thermolysin (EC number 3.4.24.27), sourced from A. caldiproteolyticus strain TP-7, to be used as a processing aid in food for the particular technological purpose of catalysing the hydrolysis of peptide bonds during the manufacture and/or processing of the following types of food, with the condition that the amount that may be used must be consistent with good manufacturing practice:
(a) dairy
(b) egg
(c) meat
(d) fish
(e) protein
(f) yeast, and
(g) flavouring.