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 A1160 which seeks to permit the use of Aspergillopepsin I (EC 3.4.23.18) from a GM strain of Trichoderma reesei as a processing aid in the manufacture of potable alcohol production and animal and vegetable protein products. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft variation to the Code.
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 draft variation to amend the table to subsection S18––9(3) in Schedule 18 of the Code to permit the use of the enzyme Aspergillopepsin I from a GM strain of T. reesei as a food processing aid in potable alcohol production and protein processing.
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 draft 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 A1160 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 27 February 2019 for a seven-week consultation period.
A Regulation Impact Statement was not required because the proposed variations to Schedule 18 are likely to have a minor impact on business and individuals.
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
The approved draft variation inserts a new entry into the table to subsection S18—9(3) in Schedule 18.
The new entry will permit the use of the enzyme, Aspergillopepsin I (EC 3.4.23.18) sourced from a GM strain of Trichoderma reesei, as a processing aid in food for a specific technological purpose, with the condition that the amount used must be consistent with good manufacturing practice. The technological purpose is for use in the potable alcohol production and protein processing.
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) established Food Standards Australia New Zealand (FSANZ) as the primary agency responsible for the development and maintenance of the Australia New Zealand Food Standards Code, which ensures the safety and quality of food products. This legislative instrument, F2019L01134, addresses a gap in the food regulatory measures by permitting the use of Aspergillopepsin I, an enzyme derived from a genetically modified strain of Trichoderma reesei, as a processing aid in the production of potable alcohol and protein products. Enacted by the Parliament of Australia, the FSANZ Act aims to provide a consistent and science-based approach to food regulation across Australia and New Zealand. This specific legislative instrument was introduced to respond to an application seeking to amend the food standards, ensuring that the use of this enzyme aligns with good manufacturing practices and existing food safety standards.
Scope and Application
The legislation outlined in F2019L01134 pertains to the Food Standards Australia New Zealand Act 1991, where Food Standards Australia New Zealand (the Authority) has been granted the responsibility of developing and varying food regulatory measures, including standards. This particular legislation focuses on the approval of a draft variation allowing the use of Aspergillopepsin I, derived from a genetically modified strain of Trichoderma reesei, as a processing aid in the manufacture of potable alcohol and in animal and vegetable protein products. The application, A1160, was accepted and considered by the Authority in line with the prescribed procedure, and a draft variation to the Australia New Zealand Food Standards Code (the Code) has been approved. This draft variation is subject to the requirements set forth by the FSANZ Act, including mandatory public consultation and subsequent consideration by the Australia and New Zealand Ministerial Forum on Food Regulation. Once approved, the Authority is required to publish a notice regarding the draft variation under section 92 of the FSANZ Act. The draft variation is not subject to disallowance or sunsetting, as specified by section 94 of the FSANZ Act. This legislative instrument does not incorporate any documents by reference but relies on existing provisions in the Code, particularly the specifications listed in 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, which provide identity and purity requirements for processing aids used in food production.
Key Provisions
The main operative sections of this legislation involve the approval of a draft variation to the Australia New Zealand Food Standards Code. This variation, detailed in Section 6 of the explanatory statement, permits the use of the enzyme Aspergillopepsin I from a genetically modified (GM) strain of Trichoderma reesei as a processing aid in the production of potable alcohol and in the processing of animal and vegetable proteins. The Authority has approved this draft variation following the consideration of Application A1160 under Division 1 of Part 3 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Section 92 of the FSANZ Act requires the Authority to publish a notice about the draft variation, while Section 94 confirms that the variation is a legislative instrument, though it is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003.
The obligations and requirements imposed by this Act primarily revolve around the approval and publication process of the draft variation. Under Section 13 of the FSANZ Act, the Authority must consider applications for the development or variation of food regulatory measures, including standards. The Authority must ensure that any applications are assessed thoroughly and in accordance with the stipulated procedures. Following the approval of the draft variation, the Authority is mandated to publish a notice about it, as per Section 92 of the FSANZ Act. The Authority must also consult with the public and stakeholders, as required by the procedures outlined in Division 1 of Part 3 of the FSANZ Act. This includes a period of public consultation to gather submissions and feedback on the draft variation. Additionally, the Authority must ensure that any approved processing aids, such as Aspergillopepsin I, comply with existing identity and purity specifications listed in relevant schedules of the Code, specifically Section 1.1.1—15 and Section S3—2 of Schedule 3.
There are no specific offences, penalties, or civil/criminal consequences mentioned in the explanatory statement for the breach of the provisions in this legislation. However, non-compliance with the standards and specifications outlined in the Australia New Zealand Food Standards Code could potentially lead to regulatory action by the Authority. The Code itself is a legislative instrument, but as stated in Section 94 of the FSANZ Act, the approved variations are not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003. The draft variation approved under this legislation is designed to ensure that any use of Aspergillopepsin I as a processing aid adheres to good manufacturing practices and meets the necessary technological requirements for its intended use in food production.