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 A1168 which sought a variation to permit a new genetically modified strain of Aspergillus niger as a source for the permitted enzyme glucoamylase. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation of a 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 draft variation to permit the enzyme glucoamylase sourced from Aspergillus niger containing the gene for glucoamylase from Talaromyces emersonii to be used as a processing aid for the purpose of hydrolysing starch in the manufacture of syrups, beverages, cereal-based products, fruit products and vegetable products, at GMP. This permission requires an addition to the table to subsection S18—9(3) in Schedule 18.
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 2017) and the United States Pharmacopeial Convention (2018) Food Chemicals Codex (11th 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 A1168 included one round of public consultation following an assessment and the preparation of a draft Standard and associated reports. Submissions were called for on 6 December 2018 for an eight-week consultation period.
A Regulation Impact Statement was not required because the proposed variation to Schedule 18 was 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 variation inserted a new entry into the table to subsection S18—9(3) in Schedule 18.
The new entry permits the use of the enzyme, glucoamylase (EC 3.2.1.3) sourced from Aspergillus niger containing the gene for glucoamylase from Talaromyces emersonii, as a processing aid in food for a specific technological purpose, with the condition that the maximum permitted level or amount that may be used must be consistent with good manufacturing practice. The technological purpose is to hydrolyse starch in the manufacture of syrups, beverages, cereal-based products, fruit products and vegetable products.
Overview
The Food Standards Australia New Zealand Amendment Regulation 2019 (F2019L00995) was enacted to address the need for updating food regulatory measures to accommodate new genetically modified strains in food processing. This regulation was introduced under the authority of section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), which empowers Food Standards Australia New Zealand (the Authority) to develop and vary standards in the Australia New Zealand Food Standards Code (the Code). The primary policy objective of this regulation is to allow the use of a new genetically modified strain of Aspergillus niger, which contains a gene from Talaromyces emersonii, as a source for the enzyme glucoamylase in various food manufacturing processes. This amendment facilitates the hydrolysing of starch in products such as syrups, beverages, and cereal-based items, under the condition that its use aligns with good manufacturing practice. Following the approval of the Authority, and after consultation with the Australia and New Zealand Ministerial Forum on Food Regulation, the regulation was published in accordance with the requirements set out in the FSANZ Act.
Scope and Application
The legislation F2019L00995 pertains to a variation in the Australia New Zealand Food Standards Code approved by Food Standards Australia New Zealand (the Authority) under the Food Standards Australia New Zealand Act 1991. This Act applies to entities involved in food manufacturing and processing, including producers, processors, and suppliers, as well as consumers who ultimately benefit from the standards set for food safety and quality. The geographic reach of this Act is both Commonwealth and national, ensuring consistency and compliance across Australia and New Zealand. The Act does not incorporate documents by reference but relies on existing provisions in the Food Standards Code that incorporate relevant identity and purity specifications listed in Schedule 3 of the Code. The Authority's consideration of the application involved a single round of public consultation, reflecting its commitment to transparency and stakeholder engagement. This variation is a legislative instrument exempt from parliamentary disallowance or sunsetting, as specified in the FSANZ Act.
Key Provisions
The key provisions of this legislation involve the variation of a standard under the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Specifically, section 13 of the FSANZ Act authorises Food Standards Australia New Zealand (the Authority) to develop standards for inclusion in the Australia New Zealand Food Standards Code (the Code). Section 92 of the Act requires the Authority to publish a notice about the standard or draft variation, and section 94 specifies that such standards or variations are legislative instruments but are not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003. The approved draft variation permits the use of a new genetically modified strain of Aspergillus niger as a source for the enzyme glucoamylase, which is to be used as a processing aid for hydrolysing starch in various food products.
The legislation imposes several obligations on the parties it governs. Firstly, the Authority must follow the procedure outlined in Division 1 of Part 3 of the FSANZ Act when considering applications for the development or variation of food regulatory measures, including conducting public consultations. The Authority must also ensure that any new standards or variations are published in accordance with section 92 of the FSANZ Act. Additionally, the Code already incorporates documents by reference, such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications and the United States Pharmacopeial Convention Food Chemicals Codex, which will prescribe identity and purity specifications for the processing aid to be permitted by the draft variation.
There are no specific offences, penalties, or civil/criminal consequences mentioned in the explanatory statement for breaches of this legislation. However, the Authority's actions and decisions are subject to scrutiny under the FSANZ Act. If a party feels that the Authority has not properly followed the legislative procedures or has made an error in its decision-making, they may have the right to seek judicial review or other remedies under the Administrative Decisions (Judicial Review) Act 1977. It is also worth noting that the 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.