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.
FSANZ accepted Application A1096 which seeks to approve a genetically modified strain of Bacillus licheniformis as a source for a protein engineered variant of the enzyme endo-1,4-β-xylanase for use in the bread-making industry. The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared variations to the Code.
Following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation[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 Legislative Instruments Act 2003.
2. Purpose
The Authority has approved a protein engineered variant of endo-1,4-β-xylanase produced by a genetically modified B. licheniformis as a processing aid. This requires an addition to the Table to clause 17 (Permitted enzymes of microbial origin) in Standard 1.3.3 – Processing Aids.
A further amendment to this Table is proposed to ensure the current scientific nomenclature is also applied to the enzyme when derived from other permitted sources. That is, the current entry for hemicellulase endo-1,4-β-xylanase is replaced by the name endo-1,4-beta-xylanase.
3. Documents incorporated by reference
The variations 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 A1096 included one round of public consultation following an assessment and the preparation of a draft Standard and associated report. Submissions were called for on 25 July 2014 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variations to Standard 1.3.3 are likely to have a minor but beneficial 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
Permissions for the new enzyme, being the protein engineered variant of endo-1,4-beta-xylanase, sourced from a genetically modified form of the microorganism Bacillus licheniformis, has been added into the Table to clause 17 of Standard 1.3.3.
The current accepted scientific common name of the enzyme is as noted above (i.e. endo-1,4-β-xylanase), which has been updated from the name currently listed in the Table for the same enzyme. Therefore changes were also made to replace the enzyme name ‘hemicellulose endo-1,4-β-xylanase’ with ‘endo-1,4-beta-xylanase’; both with the same EC number of 3.2.1.8.
FSANZ decided to replace the ‘β’ symbol with the written term ‘beta’ in the nomenclature for the new enzyme entries since Greek symbols in the Code are not always correctly displayed when the Code is viewed using certain types of electronic platforms.
[1] convening as the Australia and New Zealand Food Regulation Ministerial Council
Overview
The Food Standards Australia New Zealand Act 1991, as amended by the legislative instrument F2015L00197, aims to update the Australia New Zealand Food Standards Code to include a genetically modified strain of Bacillus licheniformis as a source for a protein engineered variant of the enzyme endo-1,4-β-xylanase for use in the bread-making industry. This change was introduced to address the need for modernising the Code in line with current scientific nomenclature and practices. The instrument was enacted by the Parliament of Australia through Food Standards Australia New Zealand (FSANZ), which is responsible for developing and varying food standards. The policy objective is to ensure that the food regulatory measures are scientifically sound, up-to-date, and facilitate innovation in the food industry. FSANZ accepted an application to approve this new enzyme after a thorough assessment and a period of public consultation, ensuring that the proposed variations have a minor but beneficial impact on business and individuals.
Scope and Application
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) governs the development of standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code (the Code), with Food Standards Australia New Zealand (the Authority) being the body responsible for this function. The Authority's consideration of applications for the development or variation of food regulatory measures, including standards, follows the procedures outlined in Division 1 of Part 3 of the FSANZ Act. Following the Authority's consideration of Application A1096, which seeks to approve a genetically modified strain of Bacillus licheniformis as a source for a protein engineered variant of the enzyme endo-1,4-β-xylanase for use in the bread-making industry, variations have been prepared for inclusion in the Code. These variations are subject to publication under section 92 of the FSANZ Act and are legislative instruments but not subject to disallowance or sunsetting under the Legislative Instruments Act 2003. The variations approved involve adding permissions for the new enzyme to the Table in clause 17 of Standard 1.3.3 and updating the scientific nomenclature to ensure consistency within the Code.
Key Provisions
The main operative sections of this legislation pertain to the approval of a genetically modified strain of Bacillus licheniformis as a source for a protein engineered variant of the enzyme endo-1,4-β-xylanase for use in the bread-making industry. Specifically, section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) empowers the Authority to develop and vary standards included in the Australia New Zealand Food Standards Code (the Code). Following the acceptance of Application A1096, the Authority has developed variations to Standard 1.3.3 – Processing Aids. These variations are intended to add the new enzyme to the Table to clause 17 (Permitted enzymes of microbial origin) and to update the scientific nomenclature for the enzyme when derived from other permitted sources.
The obligations imposed by this Act on the parties it governs include the mandatory public consultation process stipulated in Division 1 of Part 3 of the FSANZ Act. The Authority conducted one round of public consultation for a six-week period, inviting submissions from 25 July 2014. This consultation process was integral to the Authority's consideration of Application A1096 and the subsequent development of the variations to the Code. Furthermore, the Authority's decision-making process involved the preparation of a draft Standard and an associated report. The Authority also ensured that the variations did not incorporate any documents by reference, thus maintaining transparency and accessibility in its regulatory measures.
In terms of potential breaches and their consequences, the legislation specifies that the approved variations to the Code, once published under section 92 of the FSANZ Act, are considered legislative instruments. However, these instruments are not subject to parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003, as outlined in section 94 of the FSANZ Act. Therefore, the primary consequences of non-compliance with these variations would be regulatory in nature, with the Authority having the authority to enforce adherence to the new standards. Although the Act does not explicitly outline criminal or civil penalties for non-compliance, the Authority's enforcement actions could include fines, legal proceedings, or other administrative measures to ensure compliance with the approved variations.