Food Standards (Application A1107 – Asparaginase from Bacillus subtilis as a Processing Aid (Enzyme)) Variation

Overview

The Food Standards Australia New Zealand Act 1991 was enacted to establish the regulatory framework governing the development and administration of food standards in Australia and New Zealand, aiming to ensure public health and safety and to provide a consistent regulatory environment across both countries. This Act addresses the need for a unified approach to food regulation, enabling the creation of standards that protect consumer health while facilitating trade and commerce in food products between Australia and New Zealand. Enacted by the Commonwealth Parliament, the Act empowers Food Standards Australia New Zealand (FSANZ) to develop and manage food standards, with the overarching policy objective of maintaining high standards of food safety and quality. The legislative instrument F2015L01919, introduced under the Food Standards Australia New Zealand Act 1991, responds to Application A1107 by FSANZ to permit the use of a genetically modified strain of Bacillus subtilis as a source for the enzyme asparaginase in food production. This addition aims to mitigate the risk of acrylamide formation during food processing. Following a consultation period, FSANZ approved the draft variation, which was subsequently reviewed by the Australia and New Zealand Ministerial Forum on Food Regulation. The instrument, exempt from the Legislative Instruments Act 2003’s disallowance and sunsetting provisions, introduces a new entry into the table of permitted processing aids in Schedule 18, thereby updating the Australia New Zealand Food Standards Code to reflect the latest scientific understanding and regulatory requirements.

Scope and Application

The legislation in question, F2015L01919, pertains to a variation of the Australia New Zealand Food Standards Code under the Food Standards Australia New Zealand Act 1991. This Act applies to Food Standards Australia New Zealand (FSANZ), an entity responsible for developing and varying food regulatory measures, including standards, to ensure food safety and quality across Australia and New Zealand. The proposed variation, which involves the approval of a new microbial source for asparaginase from a genetically modified strain of Bacillus subtilis, targets food producers and processors who utilise this enzyme as a processing aid to mitigate acrylamide formation. The legislative instrument is not subject to parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003. The Act extends its application to the entire Commonwealth of Australia and New Zealand, thus affecting the food industry nationwide. The legislative process includes public consultation, as mandated by Division 1 of Part 3 of the FSANZ Act, but does not incorporate any documents by reference. This variation does not require a Regulation Impact Statement due to its anticipated minor impact on business and individuals. Additionally, the instrument is exempt from the need for a statement of compatibility with human rights, as it is classified as a non-disallowable instrument under section 94 of the FSANZ Act.

Key Provisions

Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) mandates the Authority's role in developing food standards and variations, which are incorporated into the Australia New Zealand Food Standards Code (the Code). Specifically, the Authority is responsible for accepting applications for the development or variation of food regulatory measures, such as standards, and for considering these applications through the process outlined in Division 1 of Part 3 of the FSANZ Act. In the case of Application A1107, the Authority approved a draft variation that seeks to permit the use of a new microbial source for asparaginase derived from a genetically modified strain of Bacillus subtilis. This variation aims to reduce the risk of acrylamide formation during food production. Following the consideration of this application and subsequent approval by the Australia and New Zealand Ministerial Forum on Food Regulation, the Authority is required under section 92 of the FSANZ Act to publish a notice regarding the draft variation. Section 94 of the FSANZ Act clarifies that such standards or variations, once a notice is published, are considered legislative instruments but are not subject to parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003. The Authority's obligations include ensuring that the development or variation of food regulatory measures follows a transparent and consultative process. In accordance with Division 1 of Part 3 of the FSANZ Act, the consideration of Application A1107 involved one round of public consultation. This consultation period, which lasted six weeks, began on 19 June 2015, and allowed stakeholders to submit their views on the draft Standard and associated report. The Authority is also required to prepare a Regulation Impact Statement if the variation is likely to have a significant impact on business and individuals; however, this was not necessary for the proposed variation to Schedule 18 as it was deemed to have a minor impact. Furthermore, 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. The variation proposed in Application A1107 specifically inserts a new entry into the Table to subsection S18–4(5) in Schedule 18. This new entry permits the use of asparaginase (EC 3.5.1.1) derived from a genetically modified form of the microorganism B. subtilis, which contains the gene for asparaginase from Pyrococcus furiosus, as a processing aid in food production. This amendment to the Code is intended to allow for the use of this enzyme to reduce the formation of acrylamide, a potentially harmful compound, in food products. The Authority's approval of this variation and its subsequent publication as a legislative instrument under section 92 of the FSANZ Act means that this new food regulatory measure is now part of the legal framework governing food production in Australia and New Zealand. The penalties for breaches of these food standards and variations are not detailed in the explanatory statement, but typically such breaches could result in enforcement actions, fines, or other legal consequences as stipulated by relevant food safety legislation.