Food Standards (Application A1153 – Endo xylanase from Trichoderma reesei as a Processing Aid) Variation

Overview

The F2018L01148 legislation, introduced as a draft variation to the Australia New Zealand Food Standards Code, was enacted in 2018. This legislative instrument was introduced under the Food Standards Australia New Zealand Act 1991 (FSANZ Act) to address the need for updating food regulatory measures concerning the use of specific processing aids in food manufacturing. Food Standards Australia New Zealand (FSANZ) accepted Application A1153 which sought to permit the use of endo-1,4-β-xylanase from a genetically modified strain of T. reesei as a processing aid in various food products. The primary objective of this draft variation was to amend the Code to allow the use of this enzyme for the depolymerisation of arabinoxylans in the manufacture and processing of bakery products, cereal products, grain, cereal-based beverages, and potable alcohol at levels generally recognised as safe. The process involved a public consultation period as mandated by Division 1 of Part 3 of the FSANZ Act, and the introduction of this processing aid was deemed a minor, deregulatory change with voluntary use.

Scope and Application

The explanatory statement outlines the approval process and intended application of a variation to the Australia New Zealand Food Standards Code by Food Standards Australia New Zealand (FSANZ). The variation seeks to permit the use of endo-1,4-β-xylanase from a genetically modified strain of T. reesei containing a xylanase gene from T. flexuosa as a processing aid for the depolymerisation of arabinoxylans during the manufacture and/or processing of bakery products, cereal products, grain, cereal based beverages (including beer), and potable alcohol at levels of Good Manufacturing Practice (GMP). This variation applies to the entities and industries involved in the production and processing of the specified food types. FSANZ considered the application in accordance with the FSANZ Act, which includes a procedure for public consultation on applications for food regulatory measures. This process ensures the proposed changes are safe and appropriate for the food supply. The variation does not incorporate any documents by reference and is exempt from the need to develop a Regulatory Impact Statement due to its minor, deregulatory nature and voluntary use. The exemption was provided by the Office of Best Practice Regulation as the introduction of the processing aid is deemed a safe addition to the food supply.

Key Provisions

The primary operative section of this legislation (section 6) allows for the insertion of a new entry into the Australia New Zealand Food Standards Code (Code). Specifically, it permits the use of endo-1,4-β-xylanase, a protein engineered variant from T. reesei containing the gene for endo-1,4-β-xylanase isolated from T. flexuosa, as a processing aid. This new entry is intended to facilitate the depolymerisation of arabinoxylans during the manufacture or processing of various food types, including bakery products, cereal products, grain, cereal-based beverages (including beer), and potable alcohol, all at levels of Good Manufacturing Practice (GMP) (section 6(1)). The obligations imposed by this legislation are primarily administrative. The Authority, under the Food Standards Australia New Zealand Act 1991 (FSANZ Act), must ensure that any applications for the development or variation of food regulatory measures, such as the use of new processing aids, are considered according to the specified procedures (section 13). This includes a requirement for public consultation and the preparation of an assessment report. In this instance, the Authority conducted one round of public consultation following an assessment and the preparation of a draft variation to the Code and assessment report (section 4). Furthermore, this legislation clarifies that the variation does not incorporate any documents by reference, simplifying the process for compliance and reference (section 3). There are no explicit offences, penalties, or civil/criminal consequences stated in this particular legislation for breaches. However, it is implied that any non-compliance with the Food Standards Australia New Zealand Act 1991 or the Food Standards Code could lead to regulatory actions, which may include fines or other enforcement measures as outlined in the FSANZ Act. Given that this is a non-disallowable instrument under section 94 of the FSANZ Act, it is exempt from the requirements for a statement of compatibility with human rights, indicating that human rights considerations have already been addressed within the broader legislative framework (section 5).