Food Standards (Application A1244 – Chymosin from GM Trichoderma reesei as a processing aid (enzyme)) Variation

Overview

The Australia New Zealand Food Standards Code Variation (Enzymes) Instrument 2022 (the Instrument) was enacted to address the need for updating food standards to accommodate new processing aids and genetically modified food products in the Australian food supply. The Food Standards Australia New Zealand Act 1991 (FSANZ Act) established the Food Standards Australia New Zealand (FSANZ) Authority to develop and vary food standards, including processing aids, subject to the approval of the Food Ministers’ Meeting (FMM). The policy objective of the FSANZ Act is to facilitate national uniform food regulation and ensure food safety and public health protection. The Instrument amends the Australia New Zealand Food Standards Code to permit the use of the enzyme chymosin, sourced from a genetically modified strain of Trichoderma reesei, as a processing aid in the manufacture of cheese, cheese products, and fermented and rennetted milk products, subject to adherence to good manufacturing practices. This amendment was approved following a consultation process and is consistent with Australia's obligations under the intergovernmental agreement and international obligations.

Scope and Application

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) empowers the Authority to develop and vary standards and variations within the Australia New Zealand Food Standards Code, encompassing a wide array of industries and entities involved in food manufacturing, processing, and distribution across the Commonwealth, state, and territory jurisdictions in Australia, as well as New Zealand. The FSANZ Act applies to any person or entity involved in the manufacture, processing, or distribution of food products within these jurisdictions, including food manufacturers, processors, distributors, and retailers. The Authority's consideration of applications such as A1244, which seeks to amend the Code to permit the use of specific processing aids, is conducted under the stipulated procedures in Division 1 of Part 3 of the FSANZ Act. Approved draft variations, like the one for chymosin sourced from a genetically modified strain of T. reesei, become legislative instruments that are publicly available and exempt from disallowance and sunsetting provisions, facilitating the establishment of an intergovernmental scheme for national uniform food regulation. These variations are not subject to disallowance or sunsetting as they give effect to an intergovernmental agreement and international obligations, with standards endorsed by the Food Ministers’ Meeting being incorporated into and enforced by the regulators of the Commonwealth, state, and territory jurisdictions as well as New Zealand.

Key Provisions

The key provisions of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) include the Authority's function to develop and vary food standards, as outlined in Section 13. The Authority's role encompasses accepting applications for the development or variation of food regulatory measures and establishing a procedure for their consideration, as detailed in Division 1 of Part 3 of the FSANZ Act. This legislative framework facilitated the acceptance and assessment of Application A1244, which sought to amend the Australia New Zealand Food Standards Code to permit the use of the enzyme chymosin, sourced from a genetically modified strain of Trichoderma reesei, as a processing aid in cheese and related products. Following the Authority's approval of a draft variation, and after endorsement by the Food Ministers’ Meeting (FMM), Section 92 of the FSANZ Act mandates the publication of a notice regarding the standard or draft variation, which is considered a legislative instrument under Section 94 of the Act. It is important to note that this instrument is not subject to parliamentary disallowance or sunsetting as per the Legislation Act 2003. The approved draft variation, being a legislative instrument, is publicly accessible on the Federal Register of Legislation. It is exempt from disallowance and sunsetting provisions as outlined in Sections 44(1) and 54(1) of the Legislation Act 2003, given that the FSANZ Act facilitates an intergovernmental scheme involving the Commonwealth and other states, and authorises the instrument to be made for the purposes of this scheme. Moreover, the FSANZ Act aligns with Australia's international obligations under agreements such as the Food Regulation Agreement and the international agreement between Australia and New Zealand. The Authority's role includes developing food standards for consideration and endorsement by the FMM, which consists of members from New Zealand, the Commonwealth, and the States/Territories. Once endorsed, these food standards are incorporated into and become part of the Commonwealth, State, Territory, and New Zealand food laws, subsequently administered, applied, and enforced by the respective regulators. The Authority has approved a draft variation that amends the Code to allow the use of the enzyme chymosin, derived from a genetically modified strain of Trichoderma reesei expressing a chymosin gene from Bos taurus, as a processing aid in the manufacture of cheese, cheese products, and fermented and rennetted milk products. This permission is contingent upon the condition that the maximum permitted level of the enzyme used must align with good manufacturing practice (GMP). The approved draft variation does not incorporate any documents by reference, but existing provisions in the Code incorporate documents by reference that will prescribe identity and purity specifications for the processing aid. Section 1.1.1—15 of the Code mandates that substances used as processing aids must comply with relevant identity and purity specifications listed in Schedule 3. Section S3—2 of Schedule 3 incorporates by reference the specifications listed in the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Combined Compendium of Food Additive Specifications and the United States Pharmacopeial Convention (2020) Food Chemicals Codex. The Authority's consideration of Application A1244 included a round of public consultation following the assessment and preparation of a draft variation and associated report, in accordance with the procedure in Division 1 of Part 3 of the FSANZ Act. The Office of Best Practice Regulation (OBPR) granted the Authority a standing exemption from the requirement to develop a Regulatory Impact Statement (RIS) for applications relating to permitting new processing aids and genetically modified food, given that such applications are deregulatory as their use is voluntary if the application is approved. This exemption was provided as permitting new processing aids and genetically modified foods is considered to be an introduction of a food to the food supply that has been determined to be safe. Finally, this instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 44 of the Legislation Act 2003. The variation allows the use of the enzyme chymosin, sourced from Trichoderma reesei containing the chymosin gene from Bos taurus, as a processing aid in the manufacture of cheese, cheese products, fermented milk products, and rennetted milk products, subject to the condition that the maximum permitted level or amount of the enzyme must be consistent with GMP.