Food Standards (Application A1165 – Lysophospholipase from Trichoderma reesei as a Processing Aid (Enzyme)) Variation

Overview

The Food Standards Australia New Zealand Amendment (2019 Enzymes) Instrument 2019 (F2019L00709) was enacted to address the need for updating food standards to permit the use of specific enzymes in food processing. This legislative instrument was introduced to facilitate the use of the enzyme lysophospholipase (EC 3.1.1.5) derived from a genetically modified strain of Trichoderma reesei as a processing aid in starch processing, including the production of syrups. The legislation was enacted by the Parliament of Australia under the authority granted by the Food Standards Australia New Zealand Act 1991 (FSANZ Act). The policy objective is to ensure that the use of food processing aids is safe and aligns with good manufacturing practices, thereby supporting innovation in food production while maintaining food safety standards.

Scope and Application

The F2019L00709 legislation pertains to the Food Standards Australia New Zealand Act 1991, governing the functions of Food Standards Australia New Zealand (FSANZ) in developing and varying food regulatory measures, including standards, within the Australia New Zealand Food Standards Code. This Act applies to food processors and manufacturers who utilise processing aids in food production, particularly in starch processing for syrup production. The legislation’s jurisdictional reach is national, extending across Australia and New Zealand, ensuring consistent food safety and regulatory standards. It specifically addresses the use of lysophospholipase (EC 3.1.1.5) derived from a genetically modified strain of Trichoderma reesei as a processing aid, subject to good manufacturing practice (GMP) conditions. The legislation does not incorporate documents by reference but relies on existing provisions of the Code and specifications from the Joint FAO/WHO Expert Committee on Food Additives and the United States Pharmacopeial Convention. The Act’s application may be extended or restricted through subordinate instruments, ensuring flexibility in adapting to new scientific findings or industry practices.

Key Provisions

The main provisions of this legislative instrument (F2019L00709) focus on the approval and publication of a variation to the Australia New Zealand Food Standards Code (the Code). Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) outlines the Authority's role in developing standards, while Division 1 of Part 3 of the same Act details the process for considering applications for new or varied food regulatory measures. Under these provisions, the Authority has accepted and assessed Application A1165, which seeks to use the enzyme lysophospholipase from a genetically modified strain of Trichoderma reesei as a processing aid in starch processing, including syrup production. Following the approval of a draft standard, section 92 of the FSANZ Act requires the Authority to publish a notice about the standard or draft variation, and section 94 confirms that such a standard or variation is a legislative instrument but not subject to parliamentary disallowance or sunsetting. The obligations imposed by the Act on the parties involved include ensuring compliance with the Code and any relevant identity and purity specifications for the processing aid. As stated in section 1.1.1—15 of the Code, any substances used as processing aids must comply with relevant specifications, which in this case are listed in Schedule 3 of the Code. This schedule incorporates by reference the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications and the United States Pharmacopeial Convention Food Chemicals Codex. The Authority is also required to conduct public consultation as part of the consideration of the application, although it was exempt from preparing a Regulatory Impact Statement for this variation due to its minor regulatory impact. Breaches of the provisions in the FSANZ Act may result in various consequences, though specific offences and penalties are not detailed in the explanatory statement. Generally, the FSANZ Act and associated regulations may include provisions for enforcement actions, fines, and other penalties for non-compliance. The approved variation itself specifies that the use of the enzyme lysophospholipase must comply with good manufacturing practice (GMP) standards, and failure to adhere to these could result in regulatory action. Additionally, the Code incorporates broader regulatory measures that may apply to the use of processing aids, which could include enforcement actions by relevant authorities in Australia and New Zealand.