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 A1130 which seeks to permit the use of the enzyme triacylglycerol lipase from a new source microorganism, being Candida cylindracea as a processing aid in the manufacture of bakery products and dairy products and in the processing of fats and oils. The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared 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 triacylglycerol lipase sourced from Candida cylindracea to be used 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 and dairy products and in the processing of fats and oils, 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 A1130 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 7 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 lipase, triacylglycerol which has the Enzyme Commission (EC) number 3.1.1.3. The source microorganism is Candida cylindracea. The prescribed technological purpose is for use in the manufacture of bakery products and dairy products and in the processing of fats and oils. The maximum permitted level is GMP.
Overview
The F2018L00033 legislative instrument was enacted in 2018 and was introduced to address the gap in the Australia New Zealand Food Standards Code (the Code) that did not permit the use of the enzyme triacylglycerol lipase sourced from Candida cylindracea as a processing aid in the manufacture of bakery products, dairy products, and in the processing of fats and oils. The Food Standards Australia New Zealand Act 1991 (FSANZ Act) empowered the Food Standards Australia New Zealand Authority (the Authority) to develop and vary standards within the Code, including accepting applications for such changes. In this instance, the Authority accepted Application A1130, which sought to permit the use of the enzyme triacylglycerol lipase from Candida cylindracea as a processing aid under certain conditions. The Authority's consideration of the application and subsequent draft variation followed the stipulated procedure under Division 1 of Part 3 of the FSANZ Act, which includes public consultation. The instrument is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003, as specified by section 94 of the FSANZ Act.
Scope and Application
The explanatory statement outlines the legislative process and rationale behind the proposed variation to the Australia New Zealand Food Standards Code, allowing the use of a specific enzyme as a processing aid in certain food products. The Authority, Food Standards Australia New Zealand, has accepted an application to permit the use of the enzyme triacylglycerol lipase sourced from Candida cylindracea in the manufacture of bakery products, dairy products, and the processing of fats and oils. The Authority has considered this application in accordance with the Food Standards Australia New Zealand Act 1991, which outlines the process for the development or variation of food regulatory measures. The proposed variation is intended to insert a new entry into the relevant section of the Food Standards Code, specifying the use of the enzyme at Good Manufacturing Practice (GMP) levels. The Authority has undertaken a round of public consultation as part of this process, and a Regulation Impact Statement was deemed unnecessary due to the minor impact of the proposed changes on businesses and individuals. This variation is exempt from human rights compatibility statements as it is a non-disallowable instrument under the FSANZ Act.
Key Provisions
The key provisions of this legislation focus on the development and variation of food regulatory measures in the Australia New Zealand Food Standards Code (the Code), specifically allowing the use of a particular enzyme as a processing aid. Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) empowers the Authority to develop and vary food standards, and this legislative instrument pertains to a variation enabling the use of triacylglycerol lipase from Candida cylindracea in certain food products (sections 13, 92, and 94). The Authority must publish a notice regarding this draft variation, as stipulated in section 92 of the FSANZ Act, and the variation itself becomes a legislative instrument under section 94, exempt from parliamentary disallowance or sunsetting.
The obligations imposed by this Act on the parties and entities it governs include adherence to the newly approved standard or variation of a standard. For instance, food manufacturers who wish to use triacylglycerol lipase from Candida cylindracea as a processing aid must now comply with the newly introduced Code variation, ensuring that the enzyme is used within the specified maximum permitted level, which is set at Good Manufacturing Practice (GMP). The Authority has already completed a round of public consultation as per the procedure outlined in Division 1 of Part 3 of the FSANZ Act, indicating a transparent and inclusive process for the development of food standards.
In terms of consequences for non-compliance, it is essential to note that while the FSANZ Act does not explicitly state penalties for breaches of the new standard or variation, non-compliance with food safety regulations generally can lead to severe civil or criminal penalties. Under state and territory food laws, penalties for non-compliance can include substantial fines and, in serious cases, imprisonment. These penalties are intended to ensure that food products are safe and that manufacturers adhere to regulatory standards to protect public health.
This legislative instrument is exempt from the requirement for a statement of compatibility with human rights, as it is a non-disallowable instrument under section 94 of the FSANZ Act. Consequently, there are no specific human rights considerations detailed within this legislative framework. However, the general principles of food safety and public health protection inherently align with the broader human rights framework by ensuring that consumers have access to safe and wholesome food. The focus on public consultation and transparent processes further underscores the commitment to protecting public interests.