Food Standards (Application A1099 – Serine Protease (Trypsin) as a Processing Aid (Enzyme)) Variation

Overview

The Food Standards Australia New Zealand Amendment Regulation 2015 (F2015L01219) was enacted to address the need for updating the Australia New Zealand Food Standards Code to include a new enzyme, serine protease (trypsin), produced by a genetically modified strain of Fusarium venenatum. This amendment was introduced by Food Standards Australia New Zealand (FSANZ) under the authority granted by section 13 of the Food Standards Australia New Zealand Act 1991. The objective of this amendment was to incorporate the approved enzyme into the permitted list of processing aids, thereby facilitating its use in food production. Following the standard procedure outlined in Division 1 of Part 3 of the FSANZ Act, FSANZ considered the application, conducted a round of public consultation, and subsequently approved the draft variations to the Code. The regulation was subject to review by the Australia and New Zealand Ministerial Forum on Food Regulation before being published as a legislative instrument under section 92 of the FSANZ Act, which is not subject to parliamentary disallowance or sunsetting.

Scope and Application

The legislation, F2015L01219, pertains to the Food Standards Australia New Zealand Act 1991 and its application to the development and variation of food regulatory measures, including standards, by Food Standards Australia New Zealand (the Authority). This Act applies to the Authority, which has the mandate to consider and approve applications for the development or variation of food regulatory measures, such as the approval of an enzyme, serine protease (trypsin), sourced from a genetically modified strain of Fusarium venenatum. This legislation is applicable across the Commonwealth of Australia and New Zealand, as it concerns the Australia New Zealand Food Standards Code. The Act does not apply to entities or individuals outside its jurisdiction or those not involved in food production or regulation. The approved enzyme, trypsin, is now permitted as a processing aid under Standard 1.3.3 – Processing Aids, as per the variations to the Code. While the Act allows for subordinate instruments to extend its application, in this instance, no additional documents were incorporated by reference. The legislation exempts itself 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.

Key Provisions

The main provisions of the legislation involve the approval of trypsin, produced by a genetically modified strain of Fusarium venenatum, as a processing aid in food production. Section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) outlines the Authority's role in developing and varying food regulatory measures, such as standards. Following the acceptance and consideration of Application A1099 under Division 1 of Part 3 of the FSANZ Act, the Authority has approved draft variations to the Australia New Zealand Food Standards Code. These variations include adding a new entry for trypsin produced by the genetically modified microorganism into the Table to clause 17 of Standard 1.3.3 – Processing Aids. This decision was communicated by the Authority in accordance with section 92 of the FSANZ Act, which mandates the publication of notices about standards or draft variations of standards. Notably, the approved variations are legislative instruments that do not fall under parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003, as specified in section 94 of the FSANZ Act. The obligations and requirements imposed by the Act on the parties and entities it governs include the submission and assessment of applications for the development or variation of food regulatory measures. For this specific case, the Authority had to follow the procedure outlined in Division 1 of Part 3 of the FSANZ Act, which includes one round of public consultation following the assessment and preparation of a draft Standard and associated report. The Authority also had to ensure that the nomenclature for the enzyme was consistent with the IUBMB naming system. Additionally, the Authority was required to convene with the Australia and New Zealand Ministerial Forum on Food Regulation to consider the application and variations, in line with section 92 of the FSANZ Act. Breaches of the provisions outlined in the FSANZ Act can lead to various consequences. While the specific Act does not detail offences, penalties, or civil/criminal consequences for breach, the FSANZ Act generally stipulates that non-compliance with food standards can result in enforcement actions by relevant authorities. These actions may include fines, legal proceedings, or other regulatory measures. The exact penalties would depend on the specific breach and the relevant provisions of the FSANZ Act and other applicable legislation. The Authority has the power to take appropriate action to ensure compliance with the food standards and variations approved under the Act.