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 A1151 which seeks to permit the use of β-galactosidase derived from a chemically mutated production strain of Papiliotrema terrestris (strain AE-BLC) as a processing aid in the production of galacto-oligosaccharide (GOS) from lactose. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft Standard.
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 draft variation of a standard.
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 Legislation Act 2003.
2. Purpose
The purpose of the variation is to permit the use of the enzyme β-galactosidase, derived from a chemically mutated production strain of Papiliotrema terrestris (strain AE-BLC), as a processing aid to produce GOS from lactose.
3. Documents incorporated by reference
The variation to food regulatory measures does 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 A1151 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 1 March 2018 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variations to Schedule 18 are 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 inserts a new entry into the table to subsection S18—9(3) in Schedule 18 of the Code.
The effect of the new entry is to permit the use of the enzyme β-galactosidase (EC number 3.2.1.23), derived from a chemically mutated production strain of Papiliotrema terrestris (strain AE‑BLC), as a processing aid in food for the technological purpose of producing GOS from lactose, subject to the condition that the amount used must be consistent with good manufacturing practice (GMP).
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) governs the development and variation of food regulatory measures, including standards, by Food Standards Australia New Zealand (FSANZ). This legislation allows the Authority to accept applications for the development or variation of food standards and stipulates the procedure for considering such applications. In line with this, FSANZ has accepted Application A1151, which proposes the use of β-galactosidase derived from a chemically mutated strain of Papiliotrema terrestris as a processing aid in the production of galacto-oligosaccharide from lactose. The Authority considered the application and has approved a draft standard after a round of public consultation. The purpose of this variation is to allow the specified enzyme to be used as a processing aid under conditions that comply with good manufacturing practice.
The enactment of this legislative instrument was conducted by the Authority in accordance with Division 1 of Part 3 of the FSANZ Act, which outlines the procedure for considering applications for food regulatory measures. The Authority is mandated to publish a notice of the draft variation under section 92 of the FSANZ Act, with the variation being considered a legislative instrument that is not subject to parliamentary disallowance or sunsetting. The decision to permit the enzyme's use is exempt from human rights compatibility statements, as it is a non-disallowable instrument as per section 94 of the FSANZ Act.
Scope and Application
The legislation outlined pertains to a variation in the Australia New Zealand Food Standards Code, specifically allowing the use of β-galactosidase derived from a chemically mutated production strain of Papiliotrema terrestris (strain AE-BLC) as a processing aid in the production of galacto-oligosaccharide (GOS) from lactose. This Act applies to entities involved in the production and processing of food within the food industry, particularly those using β-galactosidase in their manufacturing processes. The scope of this Act is national, applying to both Australia and New Zealand as per the jurisdiction of the Australia New Zealand Ministerial Forum on Food Regulation. The legislation does not specify exclusions or exemptions but mandates compliance with good manufacturing practice (GMP) conditions for the amount of enzyme used. This Act extends its application through subordinate instruments under the FSANZ Act, which allows for the development and variation of food regulatory measures.
Key Provisions
The main operative sections of this legislation revolve around the introduction of a new processing aid in the production of galacto-oligosaccharide (GOS) from lactose. Specifically, section 92 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) mandates the publication of a notice about the draft variation of a standard, while section 94 specifies that such a variation is a legislative instrument, but not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003. The substantive change introduced by this legislation is detailed in Item [1] of the variation, which inserts a new entry into subsection S18—9(3) in Schedule 18 of the Australia New Zealand Food Standards Code. This new entry permits the use of the enzyme β-galactosidase derived from a chemically mutated production strain of Papiliotrema terrestris (strain AE-BLC) as a processing aid in food for the technological purpose of producing GOS from lactose, subject to the condition that the amount used must be consistent with good manufacturing practice (GMP).
The Act imposes specific obligations on parties and entities it governs, primarily centred on compliance with the newly introduced food regulatory measures. Entities using β-galactosidase derived from the specified strain of Papiliotrema terrestris must ensure that the use of the enzyme adheres to good manufacturing practices. This includes adhering to the specified conditions regarding the amount of enzyme used and ensuring that it aligns with the technological purpose of producing GOS from lactose. The Authority’s role under the FSANZ Act is to monitor and ensure compliance with these newly established standards, thereby safeguarding food safety and quality.
Regarding potential breaches, the legislation does not explicitly outline specific offences, penalties, or civil/criminal consequences for non-compliance. However, it is implied that any non-compliance with the newly established food regulatory measures could potentially lead to enforcement actions under the FSANZ Act. This may include regulatory sanctions, fines, or other corrective measures to ensure adherence to the standards set forth by the Authority. While the exact penalties are not detailed in the provided explanatory statement, they would likely be determined in accordance with the broader provisions of the FSANZ Act and related legislation. The focus remains on ensuring that all food production processes using the specified enzyme comply with the stipulated conditions to maintain food safety and quality standards.