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 A1218 which seeks approval for a β-galactosidase (EC 3.2.1.23) enzyme derived from a new genetically modified source to be used as a processing aid in lactose reduced dairy food production. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft variation.
Following consideration by the Food Ministers’ Meeting[1], 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 amending the table to section S18––9(3) of the Code to permit the use of the enzyme, β-galactosidase (EC 3.2.1.23) sourced from Bacillus subtilis containing the β-galactosidase gene from Lactobacillus delbrueckii subsp.[2] bulgaricus, as a processing aid in the production of lactose reduced dairy foods.
3. Documents incorporated by reference
This variation does not incorporate any documents by reference.
However, section 1.1.1—15 of the Code requires certain substances (such as processing aids) to comply with any relevant identity and purity specifications listed in Schedule 3. Schedule 3 incorporates documents by reference to set specifications for various substances in the circumstances specified in that Schedule. The documents incorporated include: the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications (FAO/WHO 2017); the United States Pharmacopeial Convention (2018) Food Chemicals Codex (11th edition); and the Commission Regulation (EU) No 231/2012.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1218 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 29 April 2021 for a six-week consultation period.
The Office of Best Practice Regulation (OBPR) granted the Authority a standing exemption from the requirement to develop a Regulatory Impact Statement (RIS) for applications relating to processing aids and genetically modified food (OBPR correspondence dated 24 November 2010, reference 12065). This standing exemption was provided as permitting new GM foods and new processing aids is deregulatory as their use will be voluntary if the application is approved. This standing exemption relates to the introduction of a food to the food supply that has been determined to be safe.
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] inserts a new entry, in alphabetical order, into the table to subsection S18—9(3) of the Code.
The new entry consists of the following substance: an enzyme, ‘β-Galactosidase (EC 3.2.1.23) sourced from Bacillus subtilis containing the β-galactosidase gene from Lactobacillus delbrueckii subsp. bulgaricus’.
The technological purpose for using this enzyme as a processing aid is ‘For use in the production of lactose reduced dairy foods’.
The permission to use this enzyme as a processing aid for the stated technological purpose is subject to the condition that the maximum permitted level or amount of this enzyme that may be present in the food must be consistent with Good Manufacturing Practice.
[1] Formerly referred to as the Australia and New Zealand Ministerial Forum on Food Regulation.
Overview
The Food Standards Australia New Zealand Act 1991, enacted by the Parliament of Australia, established the Food Standards Australia New Zealand (FSANZ) Authority, which is responsible for developing and varying standards for food regulation in Australia and New Zealand. This legislation was introduced to address the need for a unified and consistent approach to food safety and labelling standards across both countries. In line with its functions, FSANZ accepted Application A1218, seeking approval for the use of a β-galactosidase enzyme derived from a genetically modified source as a processing aid in lactose-reduced dairy food production. Following a consultation process and review by the Food Ministers’ Meeting, the Authority approved a draft variation permitting the use of this enzyme under specific conditions, as detailed in the Australia New Zealand Food Standards Code. The legislative instrument, while subject to public notice, is not subject to parliamentary disallowance or sunsetting, reflecting its regulatory nature and the policy objective of facilitating safe and voluntary use of approved food substances.
Scope and Application
The Food Standards Australia New Zealand Act 1991 authorises Food Standards Australia New Zealand to develop and vary food regulatory measures, including standards, within the Australia New Zealand Food Standards Code. The Act applies to the Authority, industry stakeholders, and consumers involved in food production and consumption across Australia and New Zealand. The approved draft variation pertains to the use of a β-galactosidase enzyme derived from a new genetically modified source as a processing aid in lactose reduced dairy food production. The enzyme's use is contingent on adhering to Good Manufacturing Practice in terms of the maximum permitted levels. The Authority’s consideration of the application included a public consultation period and was exempt from producing a Regulatory Impact Statement due to the deregulatory nature of the approval, which is voluntary for industry. The draft variation is a legislative instrument under section 94 of the FSANZ Act, exempt from disallowance and sunsetting provisions. This Act extends its application through subordinate instruments, which detail specific standards and procedures for food regulatory measures.
Key Provisions
The key operative sections of this legislation are sections 13, 92, 94, and 1.1.1-15 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act), which together with the associated Code, facilitate the development and approval of food regulatory measures. Section 13 of the FSANZ Act empowers Food Standards Australia New Zealand (the Authority) to develop or vary standards for inclusion in the Australia New Zealand Food Standards Code (the Code). Section 92 of the FSANZ Act requires the Authority to publish a notice about the standard or draft variation of a standard, and section 94 specifies that such a standard, or a variation of a standard, is a legislative instrument that is not subject to parliamentary disallowance or sunsetting. Section 1.1.1-15 of the Code mandates that certain substances, including processing aids, must comply with relevant identity and purity specifications listed in Schedule 3, which incorporates documents by reference to set these specifications.
The obligations and requirements imposed by this legislation on the parties or entities it governs include the need to adhere to the procedure specified in Division 1 of Part 3 of the FSANZ Act for considering an application for the development or variation of food regulatory measures. This procedure includes one round of public consultation following an assessment and the preparation of a draft variation and associated report. The Authority is also required to publish a notice about the standard or draft variation of a standard as per section 92 of the FSANZ Act. Furthermore, any substances such as processing aids must comply with the relevant identity and purity specifications listed in Schedule 3 of the Code, which incorporates documents by reference.
The legislation does not explicitly detail offences, penalties, or civil/criminal consequences for breach. However, the requirement to comply with the Code and its associated schedules ensures that any non-compliance could potentially lead to regulatory action or enforcement measures by the relevant authorities. Since the instrument is a non-disallowable legislative instrument under section 94 of the FSANZ Act, it is not subject to parliamentary disallowance or sunsetting, which underscores the binding nature of compliance with the approved standards and variations.