Food Standards (Application A1182 – Glucose Oxidase from a GM Trichoderma reesei as a Processing Aid (Enzyme)) Variation

Overview

The F2020L00570 legislation, introduced under the Food Standards Australia New Zealand Act 1991, addresses the need to update and regulate the use of specific processing aids in food production. Enacted to enhance food safety and regulatory compliance, this legislation permits the use of a glucose oxidase enzyme preparation derived from a genetically modified Trichoderma reesei for use in the manufacture and processing of certain foods. The Food Standards Australia New Zealand Authority (FSANZ) developed this draft variation in response to an application, following a thorough assessment process that included public consultation. The purpose of this legislation is to update the Australia New Zealand Food Standards Code by allowing the specified enzyme as a processing aid for bakery, cereal-based products, and egg processing, provided its use adheres to good manufacturing practice standards. The enactment of this legislation by the relevant Australian and New Zealand Ministerial Forum on Food Regulation aims to ensure that any new processing aids introduced into the food supply are safe for consumption. The legislative instrument, as outlined, does not require parliamentary disallowance or sunsetting, reflecting its minor, deregulatory nature. By updating the regulatory framework, the legislation facilitates the introduction of safe, innovative food processing technologies, thereby supporting industry practices while maintaining high standards of food safety.

Scope and Application

The legislation outlined in F2020L00570 pertains to a variation in the Australia New Zealand Food Standards Code, specifically concerning the use of glucose oxidase enzyme preparation derived from a genetically modified Trichoderma reesei strain as a processing aid in food production. This Act applies to entities involved in the manufacture and processing of foods, particularly those producing bakery and cereal-based products, as well as those involved in egg processing. The legislation is enacted under the authority granted to Food Standards Australia New Zealand (FSANZ) by the Food Standards Australia New Zealand Act 1991, which allows FSANZ to develop and vary standards within the Code. The application of this Act is national, covering both Australia and New Zealand, as it is governed by the bi-national FSANZ regulatory framework. While the Act extends to all relevant industries and food processing entities within the jurisdictions of Australia and New Zealand, it does not include any specific exclusions or thresholds within the explanatory statement, implying a broad application across the specified industries and products. The Act’s provisions are subject to modification through subordinate instruments, which may further detail conditions or specific requirements for the use of the enzyme.

Key Provisions

The main sections of this legislation revolve around the approval of a draft variation to the Australia New Zealand Food Standards Code (the Code). Under section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), the Authority (Food Standards Australia New Zealand) has the function to develop standards and variations of standards for inclusion in the Code (Section 13). The Authority accepted application A1182 which sought to permit the use of glucose oxidase enzyme preparation from a particular genetically modified Trichoderma reesei (GM T. reesei) as a processing aid for use in the manufacture and processing of specified foods. After due consideration and public consultation, the Authority approved a draft variation of the Code to permit this enzyme for specific technological purposes (Section 92). The obligations imposed by this Act on the parties or entities it governs include the requirement for the Authority to publish a notice about the standard or draft variation of a standard once it has been approved (Section 92). The Authority is also required to consider applications for the development or variation of food regulatory measures in accordance with the procedure outlined in Division 1 of Part 3 of the FSANZ Act. Additionally, the Authority must ensure that any approved processing aids comply with relevant identity and purity specifications, as prescribed by existing provisions of the Code and incorporated documents (Section 1.1.1—15). The Authority has the discretion to exempt itself from the requirement to develop a Regulatory Impact Statement for minor, deregulatory changes such as the introduction of additional processing aids (Office of Best Practice Regulation correspondence dated 24 November 2010 - reference 12065). Any breaches of the obligations and requirements set out in this Act could result in civil or criminal consequences, although specific offences, penalties, or consequences are not detailed in the provided text. However, it is noted that the approved standard or variation of a standard, once published, becomes a legislative instrument under the FSANZ Act and is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003 (Section 94). The approved variation permits the use of glucose oxidase enzyme preparation from a particular GM T. reesei as a processing aid, subject to the condition that its use must be consistent with good manufacturing practice (GMP). The use of this enzyme is voluntary and is intended to be safe for consumption, which implies that non-compliance with the approved conditions could result in regulatory action being taken against the offending party.