Food Standards (Application A1204 – Beta-amylase from soybean (Glycine max) as a processing aid (enzyme)) Variation

Overview

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) serves as a foundational piece of legislation establishing the functions and powers of Food Standards Australia New Zealand (FSANZ) in developing food standards and variations for the Australia New Zealand Food Standards Code (the Code). This Act was enacted to ensure that food standards and related regulations are scientifically sound, consistent with international best practices, and ultimately safeguard public health and consumer protection. In line with this purpose, the FSANZ Act allows FSANZ to consider applications for the development or variation of food regulatory measures, including standards, and mandates public consultation where appropriate. The legislative instrument F2021L00671, introduced under the FSANZ Act, addresses the gap in the current regulatory framework by proposing a draft variation to permit the use of the enzyme beta-amylase sourced from soybeans as a processing aid in starch processing for the manufacture of maltose syrup. This change was subject to public consultation and has been approved by the Authority following assessment and consultation processes. The proposed variation is a minor, deregulatory change aimed at introducing a food product deemed safe into the food supply, and its implementation is voluntary. The Office of Best Practice Regulation has exempted this variation from requiring a Regulatory Impact Statement due to its anticipated minor impact on businesses and individuals.

Scope and Application

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) authorises Food Standards Australia New Zealand (the Authority) to develop and vary food regulatory measures, including standards, for inclusion in the Australia New Zealand Food Standards Code. This legislation applies to entities and individuals involved in food production and processing within Australia and New Zealand. In this instance, the Authority has approved a draft variation permitting the use of the enzyme beta-amylase from soybean as a processing aid in starch processing to manufacture maltose syrup. This approval follows a thorough review process that included public consultation, in line with the requirements of the FSANZ Act. The draft variation will be published as a legislative instrument, which is exempt from parliamentary disallowance and sunsetting provisions. The application of this variation is limited to the use of beta-amylase in food processing for the specified technological purpose, subject to conditions ensuring its use is consistent with good manufacturing practices. Notably, this change is exempt from the need for a Regulatory Impact Statement and a statement of compatibility with human rights due to its minor regulatory impact and voluntary nature.

Key Provisions

The primary operative sections of this legislation pertain to the approval and publication of a draft variation for the use of a specific enzyme in food processing. Under section 92 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act), the Authority must publish a notice regarding any standard or draft variation of a standard, which in this case involves the enzyme, beta-amylase (β-Amylase) from soybean (Glycine max) as a processing aid for starch processing to manufacture maltose syrup. This follows the procedure outlined in Division 1 of Part 3 of the FSANZ Act, which includes accepting applications for the development or variation of food regulatory measures and conducting public consultation as necessary. The draft variation approved by the Authority amends the table to section S18–9(3) of the Australia New Zealand Food Standards Code (the Code) to permit the use of β-Amylase from soybean as a processing aid, subject to certain conditions. The obligations imposed by the Act on the relevant parties are primarily administrative and procedural. The Authority is mandated to consider applications for variations in food regulatory measures, including public consultation as part of this process. The Authority must also ensure that any approved variations are published in accordance with section 92 of the FSANZ Act. Furthermore, any variation of the Code, once published, becomes a legislative instrument, although it is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003 as per section 94 of the FSANZ Act. This means that while the Authority must follow a formal process to approve and publish variations, the resultant legislative instrument will take effect without further parliamentary scrutiny. The legislation does not explicitly state any offences or penalties for breach. However, it is implied that non-compliance with the FSANZ Act's procedures for considering and approving variations could result in legal challenges or administrative consequences. The use of β-Amylase as a processing aid is subject to the condition that its presence in food must be consistent with good manufacturing practice, indicating a regulatory oversight role rather than penal consequences for breach. The Authority's approval and publication of the draft variation are the primary means of ensuring compliance with the legislative framework, with the Code acting as a guideline for industry practices.