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 A1194 which seeks permission to use a new microbial source of the already permitted enzyme processing aid, glucoamylase (EC 3.2.1.3) for use in brewing, the manufacture of bakery products, the production of potable alcohol and starch processing. The enzyme is derived from a genetically modified (GM) strain of Trichoderma reesei (T. reesei) modified to contain additional functional copies of the glucoamylase gene from T. reesei itself. 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 T. reesei modified to contain additional functional copies of the glucoamylase gene from T. reesei itself, as a processing aid in brewing, the manufacture of bakery products, the production of potable alcohol and starch processing.
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 A1194 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 12 June 2020 for a six-week consultation period.
The Office of Best Practice Regulation (OBPR) granted FSANZ a standing exemption from the requirement to develop a Regulatory Impact Statement for permitting the use of new processing aids (OBPR correspondence dated 24 November 2010, reference number 12065). This standing exemption was provided as permitting new processing aids is machinery in nature and the use of the new processing aid is voluntary once the application has been successfully approved. This standing exemption relates to the introduction of a processing aid 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] of the variation amends Schedule 18 of the Code by inserting 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 Trichoderma reesei containing the glucoamylase gene from Trichoderma reesei’ for use as a processing aid in food for specific technological purposes.
The technological purposes for this enzyme are ‘For use in brewing, the manufacture of bakery products, the production of potable alcohol and starch processing’.
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’ which is the accepted name used by the International Union of Biochemistry and Molecular Biology (IUBMB) for the enzyme with EC number 3.2.1.3 (IUBMB 2017).
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) is the principal legislation governing the regulation of food standards in Australia and New Zealand. Enacted to ensure that food is safe and correctly labelled, the Act addresses the need for a coordinated approach to food standards, ensuring consumer protection and facilitating trade between the two countries. The FSANZ Act established Food Standards Australia New Zealand (FSANZ), an independent statutory body responsible for developing food standards and administering the Australia New Zealand Food Standards Code (the Code). The policy objective of the Act is to protect public health and safety by ensuring food is safe, correctly labelled, and of acceptable quality. The explanatory statement provided outlines the FSANZ Authority's consideration and approval of a draft variation to permit the use of a new microbial source of the enzyme glucoamylase in various food processing applications, subject to public consultation and following a safety assessment.
Scope and Application
The legislative instrument F2020L01516 under the Food Standards Australia New Zealand Act 1991 relates to the approval of a draft variation permitting the use of a genetically modified microbial source of glucoamylase as a processing aid in various food-related industries. The application, A1194, was accepted by Food Standards Australia New Zealand (FSANZ), which is responsible for developing and varying food regulatory measures as specified in the FSANZ Act. The approved draft variation permits the use of glucoamylase derived from a genetically modified strain of Trichoderma reesei in brewing, the manufacture of bakery products, the production of potable alcohol, and starch processing. This amendment is subject to the condition that the enzyme's presence in food complies with good manufacturing practices. The geographic reach of this legislation is Australia and New Zealand, as FSANZ operates under both jurisdictions. There are no documents incorporated by reference in this variation, and the process included one round of public consultation in accordance with the FSANZ Act. The instrument is exempt from the requirements for a statement of compatibility with human rights and does not fall under parliamentary disallowance or sunsetting provisions.
Key Provisions
The key sections of this legislation, F2020L01516, revolve around the approval and variation of food regulatory measures under the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Specifically, section 13 of the FSANZ Act empowers Food Standards Australia New Zealand (the Authority) to develop standards and variations for inclusion in the Australia New Zealand Food Standards Code (the Code). The Authority has accepted an application (Application A1194) to permit a new microbial source of the enzyme glucoamylase (EC 3.2.1.3), derived from a genetically modified strain of Trichoderma reesei, for use in brewing, bakery products, potable alcohol, and starch processing. The Authority’s approval of this draft variation follows the stipulated procedures outlined in Division 1 of Part 3 of the FSANZ Act, and the Australia and New Zealand Ministerial Forum on Food Regulation has subsequently endorsed the variation.
The obligations imposed by this legislation primarily concern the Authority and the food industry. The Authority is mandated to consider applications for the development or variation of food regulatory measures, including standards, as stipulated in Division 1 of Part 3 of the FSANZ Act. It must also publish a notice regarding the draft variation of a standard as per section 92 of the FSANZ Act. The food industry, in turn, must ensure that any use of the newly approved enzyme complies with the maximum permitted levels consistent with good manufacturing practice, as outlined in the approved variation.
The legislation does not explicitly detail criminal or civil penalties for non-compliance with the approved variation. However, the FSANZ Act provides a framework under which non-compliance with food standards and variations could lead to enforcement actions. Such actions might include fines, court orders, or other regulatory measures aimed at ensuring compliance with food safety and quality standards. Additionally, any significant breaches could potentially attract broader legal scrutiny under other relevant Australian laws, such as those pertaining to food safety and consumer protection.
This variation to the Code is subject to specific conditions and requirements, such as ensuring the enzyme levels used in food production align with good manufacturing practices. These conditions aim to maintain the safety and quality of food products while allowing for the beneficial use of the new microbial source of glucoamylase. The Authority’s process included a round of public consultation to gather feedback and ensure transparency and inclusivity in the decision-making process. The exemption from developing a Regulatory Impact Statement, granted by the Office of Best Practice Regulation, highlights the voluntary nature of using new processing aids once approved.
This legislation does not incorporate any documents by reference and 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. The approved variation amends the Code by adding a new entry for the enzyme glucoamylase sourced from a genetically modified strain of Trichoderma reesei, specifying its use in various food production processes under the stipulated conditions.