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 A1184 which seeks permission to use the enzyme glucoamylase (EC 3.2.1.3) from a genetically modified (GM) strain of Aspergillus niger (A. niger) as a processing aid in starch processing and the production of potable alcohol. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation.
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 amending the table to subsection S18––9(3) of the Code to permit the use of the enzyme glucoamylase (EC 3.2.1.3), sourced from A. niger containing the glucoamylase gene from Trametes cingulata (T. cingulata) as a processing aid in starch processing and the production of potable alcohol.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1184 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 11 February 2020 for a six-week consultation period.
The Office of Best Practice Regulation (OBPR) granted the Authority 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
The variation inserts a new entry, in alphabetical order, into the table to subsection S18—9(3) of the Code.
The new entry consists of the enzyme ‘Glucoamylase (EC 3.2.1.3), sourced from Aspergillus niger containing the glucoamylase gene from Trametes cingulata’, for use as a processing aid in food for specific technological purposes.
The technological purposes for this enzyme are ‘For use in starch processing and the production of potable alcohol’.
The permission 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.
The variation refers to ‘glucoamylase’, although the International Union of Biochemistry and Molecular Biology (IUBMB) uses the accepted name of ‘glucan 1,4-α-glucosidase’, with ‘glucoamylase’ being listed as an alternative name for the enzyme with EC number 3.2.1.3 (IUBMB 2017).
Overview
The Food Standards Australia New Zealand Amendment Instrument 2020 (F2020L01111) was enacted to amend the Australia New Zealand Food Standards Code by permitting the use of a specific enzyme as a processing aid in starch processing and the production of potable alcohol. This legislative instrument was introduced to address the need for updating food regulatory measures to accommodate advancements in food processing technology while ensuring food safety. The enacting body was the Parliament of Australia, under the Food Standards Australia New Zealand Act 1991 (FSANZ Act), with the policy objective of facilitating minor, deregulatory changes that allow for the introduction of safe food products into the food supply. The Authority considered public consultation submissions and, following approval, published a notice about the draft variation in accordance with the FSANZ Act. The legislative instrument is exempt from parliamentary disallowance and does not require a Regulatory Impact Statement due to its minor impact on business and individuals.
Scope and Application
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) empowers Food Standards Australia New Zealand (the Authority) to develop and vary food regulatory measures, including standards, in the Australia New Zealand Food Standards Code (the Code). In accordance with these provisions, the Authority has approved a draft variation to allow the use of the enzyme glucoamylase, sourced from a genetically modified strain of Aspergillus niger containing the glucoamylase gene from Trametes cingulata, as a processing aid in starch processing and the production of potable alcohol. The Authority's decision follows the acceptance of an application (A1184) and a process that included public consultation. This variation, which is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003, is intended to facilitate the introduction of a food product deemed safe for the food supply. The use of this processing aid remains voluntary, and its application is subject to conditions ensuring the enzyme's presence in food aligns with good manufacturing practice. The Authority's consideration of this variation was exempt from the requirement to develop a Regulatory Impact Statement, given its anticipated minor impact on businesses and individuals.
Key Provisions
Section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) establishes the Authority's role in developing and varying food standards, with Section 13 detailing the process for considering such applications. In this case, the Authority has approved a draft variation permitting the use of glucoamylase, an enzyme sourced from a genetically modified strain of Aspergillus niger containing the glucoamylase gene from Trametes cingulata, as a processing aid in starch processing and the production of potable alcohol. This approval follows a thorough review process, including a public consultation period as outlined in Division 1 of Part 3 of the FSANZ Act.
The obligations imposed by the FSANZ Act on the Authority include the necessity to accept applications for the development or variation of food regulatory measures, consider these applications according to the specified procedures, and publish a notice about any draft variations. Section 92 mandates that the Authority must publish a notice regarding the draft variation, while Section 94 clarifies that such variations are legislative instruments but are exempt from parliamentary disallowance or sunsetting under the Legislation Act 2003.
The approved variation, which permits the use of the specified enzyme as a processing aid, comes with the condition that its maximum permitted level must align with good manufacturing practices. Additionally, the FSANZ Act ensures transparency and stakeholder engagement by requiring public consultation, as highlighted in the consideration of Application A1184. This process includes soliciting submissions from the public during a designated consultation period.
Failure to comply with the provisions of the FSANZ Act or the approved variations may result in legal consequences. While the specific penalties for breaches are not detailed in the provided text, it is clear that non-compliance could lead to enforcement actions by regulatory authorities. The FSANZ Act itself does not specify maximum penalties for breaches, but related legislation or regulations might outline these consequences. The legislative framework is designed to ensure that any food regulatory measures are safe, effective, and subject to appropriate scrutiny and approval processes.