Food Standards (Application A1061 – Amylomaltase as a Processing Aid (Enzyme)) Variation

Overview

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) established Food Standards Australia New Zealand (FSANZ) to develop and maintain the Australia New Zealand Food Standards Code (the Code). Enacted by the Australian Parliament, the Act aims to ensure the safety and quality of the food supply across both countries. In response to Application A1061, FSANZ has prepared a draft variation to permit the use of a new enzyme processing aid, amylomaltase sourced from genetically modified Bacillus amyloliquefaciens containing the gene for amylomaltase derived from Thermus thermophilus, for producing modified potato starch as an ingredient in food. This variation was considered in line with the FSANZ Act's provisions and underwent public consultation. The Authority’s decision follows the approval of the draft variation by the COAG Legislative and Governance Forum on Food Regulation, with the proposed change to Standard 1.3.3—Processing Aids, enabling the use of this enzyme under specified conditions. This legislative instrument does not incorporate documents by reference and is exempt from a Statement of Compatibility with Human Rights as it is a non-disallowable instrument under section 94 of the FSANZ Act.

Scope and Application

The Act pertains to the regulation and development of food standards in Australia and New Zealand, overseen by Food Standards Australia New Zealand (FSANZ), as established under section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act). The Act applies to the Authority and its procedures for accepting and considering applications for the development or variation of food regulatory measures, including standards. The scope of the Act extends to the publication of notices regarding standards or draft variations, as mandated by section 92 of the FSANZ Act, and the subsequent enactment of these standards or variations as legislative instruments under section 94, which are exempt from parliamentary disallowance or sunsetting. This legislation operates across the Commonwealth, encompassing both Australia and New Zealand, with its regulatory measures being applicable to the food industry and any entities involved in food manufacturing, ensuring that all food products meet the set safety and quality standards. The Act does not incorporate any documents by reference and, in the case of the proposed variation concerning amylomaltase, it was subject to a single round of public consultation as per the Act’s procedural requirements.

Key Provisions

The main operative sections of this legislation include sections 13, 92, and 94 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Section 13 establishes the Authority's function in developing food standards and variations, while section 92 requires the Authority to publish a notice about a draft variation of a standard. Section 94, in turn, specifies that the draft variation of a standard is a legislative instrument, exempt from parliamentary disallowance or sunsetting. The legislation seeks to amend Standard 1.3.3 – Processing Aids, by inserting an entry that permits the use of amylomaltase from genetically modified B. amyloliquefaciens in food manufacturing. This variation is subject to acceptance by the COAG Legislative and Governance Forum on Food Regulation. The obligations and requirements imposed by this legislation include the Authority's responsibility to consider applications for the development or variation of food regulatory measures, including standards. The Authority must also publish a notice about the standard or draft variation of a standard in accordance with section 92 of the FSANZ Act. Furthermore, the Authority is required to conduct public consultation as part of the consideration process for such applications. In this instance, the Authority carried out one round of public consultation following the assessment and preparation of the draft Standard. The legislation does not explicitly outline any offences, penalties, or civil/criminal consequences for breach. However, it is important to note that the draft variation of a standard is a legislative instrument exempt from parliamentary disallowance or sunsetting under section 94 of the FSANZ Act. Therefore, any breach of the newly amended standard would be subject to the applicable laws and regulations governing food safety and standards in Australia and New Zealand. The Authority may also take enforcement action against entities found in violation of the amended standard.