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 a food regulatory measure.
The Authority accepted application A1159 which sought to permit the use of the enzyme triacylglycerol lipase (EC 3.1.1.3) sourced from a genetically-modified (GM) strain of Trichoderma reesei (T.reesei) as a processing aid for the production of bakery products, and cereal-based beverages and foods. 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 Authority has approved the draft variation to amend the table to subsection S18––9(3) in Schedule 18 of the Code to permit the use of lipase, triacylglycerol (EC 3.1.1.3) sourced from a GM strain of T. reesei as a food processing aid in the production of bakery products, and cereal-based beverages and foods.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
Existing provisions of the Code incorporate a document by reference that will prescribe identity and purity specifications for the processing aid to be permitted by the variation. Section 1.1.1—15 of the Code requires substances used as processing aids to comply with any relevant identity and purity specifications listed in Schedule 3 of the Code. Section S3—2 of Schedule 3 incorporates by reference the specifications listed in the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications (FAO/WHO 2017) and the United States Pharmacopeial Convention (2018) Food Chemicals Codex (11th edition). These include specifications for enzyme preparations used in food processing.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of application A1159 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 5 February 2019 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 (OBPR reference number 12065).
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 approved draft variation inserts a new entry into the table to subsection
S18—9(3) in Schedule 18.
The new entry would permit the use of the enzyme, lipase, triacylglycerol (EC 3.1.1.3) sourced from T. reesei containing the gene for lipase, triacylglycerol isolated from A. tubingensis as a processing aid. The specific technological purpose of this enzyme processing aid would be for the production of bakery products, and for the production of cereal-based beverages and foods. A condition of the permission is that the maximum permitted level or amount that may be used must be consistent with good manufacturing practice.
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) is an Act of the Australian Parliament that establishes Food Standards Australia New Zealand (FSANZ) as the body responsible for developing food standards and regulations in Australia and New Zealand. The Act aims to ensure the safety and quality of the food supply chain by providing a science-based, consistent, and transparent food regulatory framework. In relation to the draft variation approved by the Authority, the explanatory statement indicates that the primary purpose is to amend the Australia New Zealand Food Standards Code to permit the use of a specific enzyme as a processing aid in the production of certain food products, following a public consultation process. This legislative instrument is not subject to parliamentary disallowance or sunsetting, as specified by section 94 of the FSANZ Act.
Scope and Application
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) provides the legislative framework for Food Standards Australia New Zealand (FSANZ) to develop and manage food standards, including variations to those standards, for the Australia New Zealand Food Standards Code (Code). This legislation applies to any person or entity involved in the production, manufacture, or supply of food products within the Commonwealth of Australia and New Zealand. The Act covers a wide range of industries including food manufacturers, processors, and retailers, ensuring compliance with food safety and quality standards. The approved draft variation, which seeks to permit the use of the enzyme triacylglycerol lipase sourced from a genetically-modified strain of Trichoderma reesei as a processing aid, specifically applies to the production of bakery products and cereal-based beverages and foods. The geographic reach of the Act extends across both Australia and New Zealand, ensuring a unified approach to food standards across these jurisdictions. There are no stated exclusions or thresholds in this specific legislative instrument, but the Act generally allows for exemptions and exclusions as deemed necessary by FSANZ. The application and enforcement of these standards can be further extended or restricted through subordinate instruments, such as regulations and guidelines issued by FSANZ.
Key Provisions
The key operative sections of the legislation revolve around the Food Standards Australia New Zealand (FSANZ) Act, particularly sections 13, 92, and 94, which govern the development, consideration, and publication of draft variations in the Australia New Zealand Food Standards Code. Section 13 allows FSANZ to develop and vary standards, while Section 92 mandates the publication of notices regarding these variations. Section 94 clarifies that such variations, once noticed, become legislative instruments but are exempt from parliamentary disallowance or sunsetting. The specific provision in focus is the draft variation approved by FSANZ to amend subsection S18–9(3) in Schedule 18 of the Code, permitting the use of a specific enzyme, triacylglycerol lipase (EC 3.1.1.3) from a genetically-modified strain of Trichoderma reesei, as a processing aid in the production of bakery products and cereal-based beverages and foods.
The Act imposes several obligations and requirements on the entities it governs. Firstly, FSANZ must accept and consider applications for the development or variation of food regulatory measures, following the procedure outlined in Division 1 of Part 3 of the FSANZ Act. This includes conducting a public consultation period to gather submissions on the proposed variation. Secondly, FSANZ is obligated to ensure that any new or varied standards comply with existing provisions in the Code, such as those in subsection S18–9(3) of Schedule 18. Additionally, any enzyme used as a processing aid must meet the identity and purity specifications listed in relevant schedules of the Code, incorporating documents like the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications.
The legislation does not specify offences, penalties, or civil/criminal consequences for breaches directly within the explanatory statement. However, FSANZ’s role in enforcing compliance with the Food Standards Code generally involves regulatory measures and potential administrative actions for non-compliance. Given that the variations approved are legislative instruments and not subject to disallowance or sunsetting, their legal enforceability and the repercussions for non-compliance would be determined under the broader regulatory framework of the FSANZ Act and associated regulations.
In summary, the approved draft variation to the Australia New Zealand Food Standards Code allows the use of a specific enzyme as a processing aid in certain food products, subject to conditions on the permissible level of use. FSANZ’s role in the development, consultation, and publication of this variation is governed by the FSANZ Act, and compliance with the Code's specifications is mandatory. Although the explanatory statement does not detail penalties for non-compliance, the enforcement of these standards would typically fall under FSANZ's regulatory purview.