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 A1135 which seeks to permit the use of a genetically modified strain of Bacillus licheniformis as a new source for the enzyme β-galactosidase (lactase) as a processing aid. The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared 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 prepared an amendment to the Code to permit a new microbial source for the enzyme ‘β-Galactosidase (EC number 3.2.1.23)’, namely Bacillus licheniformis containing the gene for β-Galactosidase isolated from Bifidobacterium bifidum.
The effect of the proposed variation is to permit the use of the enzyme β-Galactosidase (EC number 3.2.1.23) derived from this new source as a processing aid in food in accordance with Standard 1.3.3– Processing aids.
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 A1135 included one round of public consultation following an assessment and the preparation of a draft Standard and associated assessment summary. Submissions were called for on 2nd February 2017 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variation to Schedule 18 is likely to have a minor 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
Item 1 of the variation amends Schedule 18 of the Code by omitting the entry for the enzyme ‘β-Galactosidase (EC 3.2.1.23)’ in the table to subsection S18––4(5) and substituting it with a new entry for that enzyme.
The new entry includes an additional microbial source for the enzyme β-Galactosidase (EC 3.2.1.23), Bacillus licheniformis, containing the gene for β-Galactosidase isolated from Bifidobacterium bifidum.
Overview
The Food Standards Australia New Zealand Act 1991 was enacted to provide a framework for the development of food standards in Australia and New Zealand, ensuring the safety and quality of food. This Act allows for the establishment of the Food Standards Australia New Zealand (FSANZ) Authority, which is tasked with creating standards and variations of standards included in the Australia New Zealand Food Standards Code (the Code). The legislation was introduced to address the need for a unified and robust regulatory framework governing food standards across the two countries, ensuring consistency and safety in food production and processing. The Authority is mandated to consider applications for the development or variation of food regulatory measures, such as standards, following a specified procedure. FSANZ has accepted an application to permit the use of a genetically modified strain of Bacillus licheniformis as a new source for the enzyme β-galactosidase (lactase) as a processing aid, following a public consultation process as stipulated in the Act. The proposed amendment to the Code seeks to permit this new microbial source for the enzyme, ensuring compliance with the existing food processing aids standard.
Scope and Application
The legislation outlined in F2017L01136 pertains to a draft variation of the Australia New Zealand Food Standards Code, prepared by Food Standards Australia New Zealand (FSANZ) in response to Application A1135. This application seeks to permit the use of a genetically modified strain of Bacillus licheniformis as a new source for the enzyme β-galactosidase (lactase) as a processing aid. The variation applies to any person or entity involved in the food industry in Australia and New Zealand, specifically those who may use β-galactosidase as a processing aid in food production. The amendment concerns a change in the microbial source of the enzyme, allowing the use of a genetically modified Bacillus licheniformis strain. This legislative instrument is a result of the FSANZ Act 1991, which governs the development and variation of food standards, and is not subject to parliamentary disallowance or sunsetting. The Authority's consideration of the application and subsequent drafting of the variation followed a process outlined in Division 1 of Part 3 of the FSANZ Act, including a public consultation period.
Key Provisions
Section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) mandates the Authority's role in developing food standards and variations of standards to be included in the Australia New Zealand Food Standards Code (Code). This role is further clarified in Division 1 of Part 3 of the FSANZ Act, which outlines the process for accepting applications for new or varied food regulatory measures, such as standards. Pursuant to these provisions, the Authority accepted Application A1135, which sought to permit a genetically modified strain of Bacillus licheniformis as a new source for the enzyme β-galactosidase (lactase) as a processing aid. This application was evaluated by the Authority, leading to the preparation of a draft variation.
In accordance with the FSANZ Act, the Authority has a duty to notify the public about the draft variation through a notice under section 92. This step ensures transparency and provides an opportunity for stakeholders to comment on the proposed changes. Additionally, section 94 of the FSANZ Act stipulates that any standard or variation of a standard, upon which a notice has been published, is considered a legislative instrument. However, it is noteworthy that such instruments are not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003.
The Authority's obligations under the FSANZ Act include the consideration of applications for food regulatory measures, conducting public consultations, and preparing draft standards. The process requires the Authority to engage in a thorough evaluation of the application, prepare an assessment summary, and publish a notice to the public. The Authority must also ensure that the consultation process is inclusive and allows for meaningful participation from all relevant stakeholders. Failure to comply with these obligations could result in legal challenges or questions about the legitimacy of the proposed standards.
Under the FSANZ Act, breaches of the Authority's obligations can lead to various consequences. While the specific penalties are not detailed in the explanatory statement, it is understood that non-compliance with the Act can result in legal actions, including judicial review. The potential civil or criminal penalties for such breaches may vary depending on the nature and severity of the non-compliance. The FSANZ Act provides a framework within which the Authority operates, and adherence to its provisions is crucial to maintaining the integrity of the food regulatory system.