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).
FSANZ had completed a review of the Code undertaken under Proposal P1025[1] in order to improve the Code’s clarity and legal efficacy. A revised Code has been approved and will commence on 1 March 2016. It will replace the existing Code, which will be repealed on that date.
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 A1099 which seeks to approve an enzyme, serine protease (trypsin), sourced from a genetically modified strain of Fusarium venenatum containing the gene for serine protease from Fusarium oxysporum, as a processing aid.
The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft variation to Standard 1.3.3 of the existing Code.
The Authority has also approved a draft variation to Schedule 18 of the revised Code to ensure that, on 1 March 2016, the revised Code is consistent with the existing Code as amended by the draft variation.
Following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation[2], section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the draft variation.
Section 94 of the FSANZ Act specifies that 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. Commencement
The approved variation to the revised Code takes effect on 1 March 2016. This is the date on which the existing Code is repealed and the revised Code comes into effect.
3. Purpose
The Authority has approved trypsin (EC 3.4.21.4) produced by a genetically modified microorganism, F. venenatum containing the gene for serine protease (trypsin) from F. oxysporum. This requires the addition of a new entry into the table to subsection S18—4(5) in Schedule 18 of the revised Code. The nomenclature for the enzyme for inclusion in Standard 1.3.3 was determined as ‘trypsin’ as this is consistent with the IUBMB naming system.
4. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
5. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1099 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 16 January 2015 for approximately a six-week consultation period.
A Regulation Impact Statement was not required because the Application is likely to have a minor but beneficial impact on business and individuals.
6. 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 Schedule to the Variation amends Schedule 18 of the revised Code by inserting a new entry into the table to subsection S18—4(5).
The new entry permits the use of trypsin (EC 3.4.21.4) from a genetically modified form of the microorganism F. venenatum, containing the gene for trypsin from F. oxysporum, as a processing aid in the production of food.
[1] http://www.foodstandards.gov.au/code/proposals/Pages/proposalp1025coderev5755.aspx
[2] convening as the Australia and New Zealand Food Regulation Ministerial Council
Overview
The Food Standards Australia New Zealand Amendment (2016 Measures) Instrument 2016 (F2015L01228) was enacted to address the need for improved clarity and legal efficacy within the Australia New Zealand Food Standards Code. The legislation, introduced by the Australian Government, aims to streamline the regulatory framework governing food standards by incorporating a revised version of the Code. This amendment follows a comprehensive review by Food Standards Australia New Zealand (FSANZ), which sought to enhance the Code’s usability and effectiveness. Pursuant to section 13 of the Food Standards Australia New Zealand Act 1991, the Authority has the responsibility to develop and vary standards within the Code. This legislative instrument facilitates the approval of an enzyme, serine protease (trypsin), derived from a genetically modified strain of Fusarium venenatum, as a processing aid. The variation ensures consistency between the existing and revised versions of the Code, which will both be repealed and replaced on 1 March 2016. The approval process included public consultation and was overseen by the Australia and New Zealand Ministerial Forum on Food Regulation, as mandated by the FSANZ Act. This amendment is not subject to disallowance or sunsetting under the Legislative Instruments Act 2003.
Scope and Application
The Food Standards Australia New Zealand (Variation) Instrument 2015, made under the Food Standards Australia New Zealand Act 1991, applies to food processing entities within the jurisdiction of Australia and New Zealand. This Act encompasses all entities involved in the production, processing, and distribution of food products in these regions, ensuring that any use of the enzyme serine protease (trypsin) derived from a genetically modified strain of Fusarium venenatum is regulated and permitted under the revised Australia New Zealand Food Standards Code. The legislation specifies the inclusion of this enzyme as a processing aid, which will be effective from 1 March 2016 when the existing Code is repealed and replaced by the revised Code. The application of this Act is not subject to parliamentary disallowance or sunsetting, as outlined in section 94 of the FSANZ Act. This legislative instrument is designed to ensure that food regulatory measures are updated to reflect scientific advancements and maintain the safety and quality of food products in both countries.
Key Provisions
The key operative sections of this legislation concern the approval of a variation to the Australia New Zealand Food Standards Code (the Code). Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) sets out the Authority's functions, including the development and variation of standards within the Code. Division 1 of Part 3 of the FSANZ Act outlines the procedure for considering applications for the development or variation of food regulatory measures, which the Authority followed in approving Application A1099. Section 92 mandates the publication of a notice regarding the draft variation, and Section 94 specifies that the variation, once approved, is a legislative instrument but not subject to parliamentary disallowance or sunsetting.
The Act imposes several obligations on the parties involved. The Authority must consider applications for variations in accordance with the procedures set out in Division 1 of Part 3 of the FSANZ Act. This includes conducting a public consultation as part of the review process. The Authority is also required to publish a notice about the draft variation under Section 92. Furthermore, the Authority must ensure that the revised Code is consistent with the existing Code as amended by the draft variation, as per the approval process outlined in the legislation.
Offences and penalties are not explicitly detailed in this legislation. However, breaches of the Food Standards Australia New Zealand Act 1991 may lead to civil or criminal consequences depending on the nature and severity of the breach. For instance, violations of food safety standards can result in fines or imprisonment, although specific penalties are not mentioned in this particular legislation. The Act classifies the approved variation as a legislative instrument under Section 94, which is not subject to parliamentary disallowance or sunsetting, thereby highlighting the importance of compliance with the approved standards and variations.