Explanatory statement
1. Authority
Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) provides that the functions of Food Standards Australia New Zealand (the Authority) include the development of standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code (the Code).
Division 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering an application for the development or variation of food regulatory measures.
The Authority accepted Application A1162 which seeks permission to use the enzyme triacylglycerol lipase (EC 3.1.1.3) from a genetically modified strain of T. reesei as a processing aid in baking and other cereal-based processes. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft Standard.
Following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation, section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the standard or draft variation of a standard.
Section 94 of the FSANZ Act specifies that a standard, or a variation of a standard, in relation to which a notice is published under section 92 is a legislative instrument, but is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003.
2. Purpose
The Authority has approved a variation to amend the table to subsection S18––9(3) in Schedule 18 of the Code to permit the use of the enzyme triacylglycerol lipase from a genetically modified strain of T. reesei as a food processing aid in baking and other cereal-based processes.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
Existing provisions of the Code incorporate a document by reference that will prescribe identity and purity specifications for the processing aid to be permitted by the variation. Section 1.1.1—15 of the Code requires substances used as processing aids to comply with any relevant identity and purity specifications listed in Schedule 3 of the Code. Section S3—2 of Schedule 3 incorporates by reference the specifications listed in the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications (FAO/WHO 2016) and the United States Pharmacopeial Convention (2016) Food Chemicals Codex (10th edition). These include specifications for enzyme preparations used in food processing.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1162 included one round of public consultation following an assessment and the preparation of a draft variation and associated assessment summary. Submissions were called for on 13 November for a five-week consultation period.
The Office of Best Practice Regulation (OBPR) granted FSANZ a standing exemption from needing to develop a Regulatory Impact Statement for proposed variations of the Code to permit additional processing aids (OBPR correspondence dated 24 November 2010 - reference 12065). This standing exemption was provided as permitting additional processing aids is likely to have only a minor impact on business and individuals. It is a minor, deregulatory change that allows for the introduction of a food product to the food supply that has been determined to be safe. The use of the approved processing aid is also voluntary.
5. Statement of compatibility with human rights
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.
6. Variation
Item [1] of the variation inserts the following into the table to subsection S18—9(3) in Schedule 18 in alphabetical order: a new entry for “lipase, triacylglycerol (EC 3.1.1.3) sourced from T. reesei containing the gene for lipase, triacylglycerol isolated from F. oxysporum” into column 1; the words “For use in the manufacture of bakery and other cereal-based products” into column 2; and “GMP” into column 3.
The new entry will, in effect, permit the enzyme triacylglycerol lipase (E.C 3.1.1.3), derived from the genetically modified strain of T. reesei, to be used as a processing aid in food, for the technological purpose of baking and other cereal-based processes, with the condition that the amount used must be consistent with good manufacturing practice (GMP).
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) was enacted to establish a framework for the regulation of food standards in Australia and New Zealand, addressing the need for harmonised food safety and quality standards across both countries. The Act empowers Food Standards Australia New Zealand (FSANZ) to develop and vary food standards, ensuring they are based on sound scientific evidence and risk assessment. The Authority is mandated to maintain the Australia New Zealand Food Standards Code, which sets out the standards for food composition, labelling, and additives. The legislative instrument F2019L00704, introduced under the FSANZ Act, seeks to amend the Code to allow the use of the enzyme triacylglycerol lipase from a genetically modified strain of T. reesei as a food processing aid in baking and other cereal-based processes. This change follows an application and approval process, including public consultation, and is intended to introduce a minor, deregulatory change that supports the safe introduction of food products into the supply chain. The policy objective is to facilitate the use of safe and approved processing aids, subject to good manufacturing practices.
Scope and Application
The F2019L00704 legislation pertains to the Food Standards Australia New Zealand Act 1991 and involves a variation to the Australia New Zealand Food Standards Code. This legislation applies to Food Standards Australia New Zealand as the regulatory body responsible for developing and varying food standards and regulations. The application of this Act spans across the Commonwealth, as it involves the collaborative efforts of Australia and New Zealand through the Ministerial Forum on Food Regulation. The Act's focus is on the approval of a specific processing aid, the enzyme triacylglycerol lipase from a genetically modified strain of T. reesei, for use in baking and other cereal-based processes. This approval was granted following a public consultation process and is consistent with good manufacturing practice (GMP) as outlined in the legislation. The legislation does not incorporate any documents by reference for the variation itself, although it does reference existing documents for identity and purity specifications that the enzyme must meet. The application of this Act is not subject to parliamentary disallowance or sunsetting, as specified in the FSANZ Act.
Key Provisions
The legislation in question pertains to the variation of food standards under the Food Standards Australia New Zealand Act 1991 (FSANZ Act) (s 13). Specifically, it involves the approval of a draft standard allowing the use of the enzyme triacylglycerol lipase from a genetically modified strain of T. reesei as a processing aid in baking and other cereal-based processes (s 92, s 94). The variation is made to Schedule 18 of the Australia New Zealand Food Standards Code (Code), modifying subsection S18–9(3) to include the new enzyme in the list of permitted processing aids (Item [1]). The inclusion requires that the enzyme's use must comply with good manufacturing practice (GMP) standards.
Under this Act, the Authority must consider applications for the development or variation of food regulatory measures, which includes a process of public consultation (s 92). For this particular variation, one round of public consultation was conducted, with submissions accepted for five weeks starting on 13 November. Additionally, the Authority has been granted a standing exemption by the Office of Best Practice Regulation (OBPR) from needing to develop a Regulatory Impact Statement for such variations, as they are considered minor and deregulatory (OBPR correspondence dated 24 November 2010 - reference 12065).
The legislation outlines certain obligations for parties involved. Food businesses using the enzyme triacylglycerol lipase must ensure that its use aligns with GMP, as stipulated in the new entry in Schedule 18. This involves adhering to the specifications for identity and purity, which are incorporated by reference from the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications and the United States Pharmacopeial Convention (USP) Food Chemicals Codex (s 1.1.1–15, Schedule 3). These specifications ensure that the enzyme used is safe and meets quality standards.
There are no specific offences, penalties, or civil/criminal consequences outlined in this legislation for breaches of the new standard. However, failure to comply with the GMP requirements and the specified identity and purity standards could lead to regulatory action under other provisions of the FSANZ Act or related food safety legislation. Such actions may include enforcement notices, fines, or other sanctions to ensure compliance and maintain food safety standards.