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 A1164 which seeks permission to use the enzyme pullulanase (EC 3.2.1.41) from a genetically modified (GM) strain of Bacillus licheniformis as a processing aid in brewing and starch processing. 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.
2. Purpose
The Authority has approved an amendment to the table to section S18––9(3) in Schedule 18 of the Code to permit the use of the enzyme pullulanase (EC 3.2.1.41) from a GM strain of B. licheniformis as a processing aid in brewing and starch 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 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 A1164 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 6 June 2019 for a six-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 in the table to subsection S18—9(3) in Schedule 18 in alphabetical order, a new entry for “Pullulanase (EC 3.2.1.41) sourced from Bacillus licheniformis containing the pullulanase gene from Bacillus deramificans” into column 1, and “For use in brewing and in starch processing” into column 2, and “GMP” into column 3.
The new entry will, in effect, permit pullulanase (EC number 3.2.1.41), derived from the GM strain of B. licheniformis, to be used as a processing aid in food, with a technological purpose of brewing and starch processing, with the condition that the amount used must be consistent with good manufacturing practice (GMP).
Overview
The Food Standards Australia New Zealand Amendment (2019 Enzymes) Instrument 2019 (F2019L01569) was enacted to address the need for updating food regulatory measures within the Australia New Zealand Food Standards Code to accommodate the use of a genetically modified enzyme as a processing aid in specific industries. This legislative instrument was introduced to amend the existing standards to allow the use of pullulanase, an enzyme derived from a genetically modified strain of Bacillus licheniformis, in brewing and starch processing. The policy objective behind this amendment is to facilitate the introduction of safe food products into the market while maintaining the integrity of food manufacturing processes. The Authority, under the Food Standards Australia New Zealand Act 1991, has approved this variation following a thorough assessment and consultation process to ensure the safety and compliance of the proposed change with existing food standards.
Scope and Application
The Act pertains to the Food Standards Australia New Zealand Authority and applies to entities and individuals involved in the brewing and starch processing industries. It specifically addresses the use of the enzyme pullulanase derived from a genetically modified strain of Bacillus licheniformis as a processing aid within these industries. The application of the Act is national in scope, extending across both Australia and New Zealand, in alignment with the regulatory functions of the Authority under the FSANZ Act. The Authority's approval of the draft variation to the Australia New Zealand Food Standards Code, following a public consultation period, is intended to permit the safe use of the specified enzyme under good manufacturing practices. The Act does not incorporate any documents by reference for this variation but references existing identity and purity specifications in the Code. There are no exclusions or exemptions specified in the Act for this particular variation, and the changes are voluntary for industry participants. The legislative process does not require a statement of compatibility with human rights, as it is deemed a minor regulatory change with a limited impact on business and individuals.
Key Provisions
The main sections of the legislation detail the process and outcome of approving a draft variation to the Australia New Zealand Food Standards Code. Under section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), Food Standards Australia New Zealand (the Authority) is responsible for developing food standards and variations of standards. The Authority accepted Application A1164, which seeks permission to use the enzyme pullulanase (EC 3.2.1.41) from a genetically modified (GM) strain of Bacillus licheniformis as a processing aid in brewing and starch processing. This application was considered under Division 1 of Part 3 of the FSANZ Act, leading to the approval of a draft variation to the Code. Section 92 of the FSANZ Act requires the Authority to publish a notice about the standard or draft variation of a standard, which has been done following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation.
The obligations imposed by this Act on the parties or entities it governs include compliance with the newly approved use of pullulanase as a processing aid in brewing and starch processing. This means that entities involved in these industries must ensure that if they use pullulanase, it is derived from the specified GM strain of Bacillus licheniformis and is used in accordance with good manufacturing practice (GMP). The Code requires that substances used as processing aids comply with relevant identity and purity specifications, which are outlined in Schedule 3 and incorporate specifications from the Joint FAO/WHO Expert Committee on Food Additives and the United States Pharmacopeial Convention.
The legislation also outlines potential consequences for non-compliance. While the explanatory statement does not specify any particular offences or penalties for breaching the approved use of pullulanase as a processing aid, general provisions in the FSANZ Act and the Australia New Zealand Food Standards Code provide for both civil and criminal penalties. These penalties can include fines and imprisonment for serious breaches, particularly if the breach results in food that is unsafe for consumption. Compliance with GMP is also critical, as deviations from these standards can lead to enforcement actions by regulatory authorities.
Additionally, the Authority’s consideration of the application included a public consultation process, ensuring that stakeholders had the opportunity to provide feedback on the proposed variation. This consultation was conducted in accordance with the procedure outlined in Division 1 of Part 3 of the FSANZ Act. The Office of Best Practice Regulation has granted the Authority a standing exemption from needing to develop a Regulatory Impact Statement for minor, deregulatory changes like this, which are unlikely to have a significant impact on business or individuals. This exemption was granted due to the minor nature of the change and its voluntary use.