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 A1169 which seeks to permit the use of an Alpha-glucosidase enzyme preparation from Trichoderma reesei which expresses the α-glucosidase gene from Aspergillus niger as a processing aid for use in the production of various foods. 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 draft variation to permit the enzyme α-glucosidase sourced from a GM T. reesei, which expresses the α-glucosidase gene from A. niger for use as a food processing aid. The permission will be listed in the table to subsection S18—9(3), which includes enzymes permitted for a specific technological purpose. The technological purpose is for use in the production of food ingredients such as potable alcohol, lysine, lactic acid, biochemicals, such as MSG and other amino acids, production of IMO syrup and other sweeteners. The level of usage is an amount consistent with 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 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 A1169 included one round of public consultation following assessment and the preparation of a draft variation and associated assessment summary. Submissions were called for on 20 June 2019 for an six-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 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, α-glucosidase (EC 3.2.1.20) sourced from a GM T. reesei, containing the α-glucosidase gene from A. niger, for use as a food 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 for use in the production of food ingredients such as potable alcohol, lysine, lactic acid, biochemicals, such as MSG and other amino acids, production of IMO syrup and other sweeteners.
Overview
The legislative instrument F2020L00025, published under the Food Standards Australia New Zealand Act 1991, pertains to the approval of a draft variation that permits the use of an Alpha-glucosidase enzyme preparation derived from Trichoderma reesei, which expresses the α-glucosidase gene from Aspergillus niger, as a processing aid in food production. The Act, enacted by the Parliament of Australia, aims to ensure the safety and quality of food products by regulating food standards and practices. The problem this legislation addresses is the need to incorporate new food processing aids into the existing food standards to keep pace with advancements in biotechnology and food production technologies. The Food Standards Australia New Zealand Authority, after considering an application and public consultation, has approved this variation, which will be listed in the relevant section of the Australia New Zealand Food Standards Code, subject to the conditions that the enzyme's usage aligns with good manufacturing practice. This legislative measure reflects the policy objective of maintaining high standards in food safety while facilitating the adoption of innovative food processing techniques.
Scope and Application
The legislative instrument F2020L00025, approved by Food Standards Australia New Zealand (FSANZ), pertains to the variation of standards under the Food Standards Australia New Zealand Act 1991, allowing the use of a specific enzyme as a food processing aid. This legislative instrument applies to food manufacturers, processors, and other industry stakeholders who use enzymes in food production within Australia and New Zealand. The Act facilitates the FSANZ's role in developing and varying food regulatory measures, including standards, and this particular variation pertains to the approval of an Alpha-glucosidase enzyme preparation from Trichoderma reesei, which expresses the α-glucosidase gene from Aspergillus niger, for use in various food processing applications. The use of this enzyme is subject to conditions consistent with good manufacturing practice and is intended for specific technological purposes such as the production of ingredients like potable alcohol, lysine, lactic acid, and other biochemicals and sweeteners. The instrument does not incorporate any documents by reference but references existing provisions in the Australia New Zealand Food Standards Code that mandate compliance with identity and purity specifications for processing aids.
Key Provisions
The main operative sections of this legislation involve the approval and variation of a food processing aid under the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Section 13 of the FSANZ Act allows Food Standards Australia New Zealand (the Authority) to develop or vary standards in the Australia New Zealand Food Standards Code (the Code). The Authority has accepted an application (A1169) to permit the use of an Alpha-glucosidase enzyme preparation from a genetically modified Trichoderma reesei, expressing the α-glucosidase gene from Aspergillus niger, as a processing aid for various food production purposes (Section 1). Following the Authority's consideration of the application, a draft standard has been approved and will be published under section 92 of the FSANZ Act (Section 1). The draft variation to be incorporated into the Code will allow the enzyme α-glucosidase, sourced from a genetically modified Trichoderma reesei, to be used as a food processing aid, with the condition that the usage level must be consistent with good manufacturing practice (GMP) (Section 2).
The Authority, under the FSANZ Act, is obligated to accept applications for the development or variation of food regulatory measures, including standards, and to consider them according to the procedures outlined in Division 1 of Part 3 of the Act (Section 1). The Authority is also required to publish a notice regarding the standard or draft variation of a standard, as stipulated by section 92 of the FSANZ Act (Section 1). The Authority must ensure that any approved standard or variation, once published, will be listed in the relevant section of the Code and will comply with existing provisions, such as those in Schedule 3, which incorporate by reference documents that prescribe identity and purity specifications for substances used as processing aids (Section 3). The Authority must also ensure that any consultation process is conducted in accordance with the Act, and where applicable, prepare a Regulation Impact Statement (Section 4).
There are no specific offences, penalties, or civil/criminal consequences outlined for breach of this legislation. However, as the approved standard or variation becomes a legislative instrument under section 94 of the FSANZ Act, it is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003 (Section 1). The Authority, in its capacity to develop or vary standards, is responsible for ensuring compliance with the approved standard or variation by relevant parties or entities. Failure to comply with the approved standard or variation may result in regulatory action, such as enforcement by food regulatory agencies or potential legal consequences for non-compliance with food safety and quality standards.