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.
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) was enacted to provide a framework for the regulation of food standards and variations of standards across Australia and New Zealand. The Act aims to ensure food safety, protect public health, and facilitate fair trade practices in the food industry. One of the key functions of Food Standards Australia New Zealand (the Authority) under the FSANZ Act is to develop standards and variations for inclusion in the Australia New Zealand Food Standards Code (the Code). Recently, the Authority considered and approved a draft variation to permit the use of a specific enzyme, aqualysin 1, sourced from Bacillus subtilis containing the aqualysin 1 gene from Thermus aquaticus, as a processing aid in the manufacture of bakery products. This variation was made in response to an application (A1131) and follows the necessary public consultation process. The Authority’s approval of this draft variation is subject to the publication requirements under the FSANZ Act, and it is important to note that such variations, while considered legislative instruments, are not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003.
Scope and Application
The legislative instrument F2018L00035 pertains to the Food Standards Australia New Zealand Act 1991 and involves a variation in the Australia New Zealand Food Standards Code, specifically addressing the use of the enzyme aqualysin 1 as a processing aid in the manufacture of bakery products. This legislation applies to entities involved in the food industry, particularly those involved in the production and processing of bakery goods, and seeks to amend the existing regulatory measures to permit the use of aqualysin 1 sourced from Bacillus subtilis containing the aqualysin 1 gene from Thermus aquaticus, subject to the conditions specified in the variation. The scope of this Act extends across both Australia and New Zealand, as it pertains to the Australia New Zealand Food Standards Code, ensuring a uniform regulatory approach between the two countries. While the Act introduces a variation to permit the use of a specific enzyme in food processing, it does not incorporate any documents by reference and has been subject to public consultation as mandated by the FSANZ Act. This variation is a legislative instrument under section 94 of the FSANZ Act and is exempt from parliamentary disallowance or sunsetting.
Key Provisions
The primary operative sections of this legislation are sections 13, 92, and 94 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Section 13 allows Food Standards Australia New Zealand (the Authority) to develop or vary food regulatory measures, including standards, for inclusion in the Australia New Zealand Food Standards Code (the Code). Section 92 mandates that the Authority must publish a notice when a standard or a draft variation is approved, following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation. Section 94 specifies that the approved standard or variation is a legislative instrument but is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003. The legislation 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 in the manufacture of bakery products at Good Manufacturing Practice (GMP) levels.
The Act imposes obligations on the Authority to consider applications for the development or variation of food regulatory measures and to follow the procedure outlined in Division 1 of Part 3 of the FSANZ Act. This includes conducting one round of public consultation as part of the consideration process. The Authority must also publish a notice of the approved variation, ensuring transparency and providing the public with an opportunity to review and comment on the changes. The Authority is responsible for ensuring that any new or varied standards align with the objectives of the Code and do not compromise food safety or public health.
Breaches of the provisions outlined in the FSANZ Act may lead to various consequences, depending on the nature and severity of the violation. While the explanatory statement does not detail specific offences, penalties, or consequences, the FSANZ Act generally provides for civil and criminal penalties for non-compliance with food standards. The maximum penalties can include fines and imprisonment for serious offences that endanger public health or safety. The Act also allows for the enforcement of compliance through court proceedings, where authorised officers may seek injunctions or other remedies against entities that do not comply with the standards or legislative instruments. The precise penalties and enforcement mechanisms are defined within the broader FSANZ Act and related legislation.