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 A1172 which sought an amendment to Schedule 3 of the Code to prescribe a new specification for rebaudioside D (Reb D) produced by a particular enzymatic conversion method. The Authority considered the application in accordance with Division 1 of Part 3 of the FSANZ Act and 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 approved a draft variation to amend subsection S3—35(2) of Schedule 3 of the Code. The amendment includes in the specification provided by that subsection a reference to the enzymatic conversion method used to produce the A1172 applicant’s Reb D. The amendment’s effect permits Reb D produced by that production method to be used as a food additive in accordance with the existing permissions and limits for steviol glycosides (including containing Reb D) in the Code.
The Authority also prepared a draft variation to amend Schedule 18 of the Code to permit the use of the specific enzyme as a processing aid in the processing of the A1172 applicant’s Reb D in accordance with Standard 1.3.3 of the Code.
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 A1172 included one round of public consultation following an assessment and the preparation of a draft variation and associated assessment summary.
A Regulation Impact Statement was not required because the proposed variations to Schedule 3 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]
Item [1] amends Schedule 3 of the Code. The item adds a new paragraph (c) to the subsection S3—35(2).
The new paragraph S3—35(2)(c) includes a reference to the enzymatic conversion of purified stevia leaf extract to produce Reb D using a protein engineered enzyme that: contains both UDP‑glucosyltransferase (EC 2.4.1.17) and sucrose synthase (EC 2.4.1.13) components; and is sourced from Pichia pastoris strain UGT-A.
The effect of this amendment is to permit Reb D produced using this method to be used as a food additive in accordance with the existing food additive permissions in the Code for steviol glycosides (including steviol glycosides containing Reb D).
Item [2]
Item [2] will amends Schedule 18. The item inserts a new entry into the table to subsection S18—9(3). The effect of the new entry is to permit the use of a specific enzyme as a processing aid in the manufacture of Reb D for the following technological purpose: the conversion of purified stevia leaf extract to produce Reb D. The permitted enzyme is a protein engineered enzyme that: contains both UDP‑glucosyltransferase (EC 2.4.1.17) and sucrose synthase (EC 2.4.1.13) components; and is sourced from Pichia pastoris strain UGT-A. The permission includes the condition that the maximum permitted amount used as a processing aid must be consistent with Good Manufacturing Practice (as defined by section 1.1.2—2(3) of the Code).
Overview
The Food Standards Australia New Zealand Amendment Regulation 2019 (F2019L01136) was enacted to address the need for updating food regulatory measures within the Australia New Zealand Food Standards Code (the Code) to accommodate new scientific and technological developments in food production and processing. This regulation was introduced by Food Standards Australia New Zealand (FSANZ), the body responsible for developing and maintaining the Code under the Food Standards Australia New Zealand Act 1991. The policy objective of this amendment is to ensure that food standards remain current and scientifically informed, thus safeguarding public health while facilitating innovation in the food industry. The Authority accepted and considered an application to modify the specifications for rebaudioside D (Reb D), a food additive derived from stevia, to include a new enzymatic conversion method. Following consultation and assessment, the Authority prepared draft variations to the Code to permit the use of Reb D produced by this method and the specific enzyme used in its production, ensuring compliance with existing food additive standards and good manufacturing practices.
Scope and Application
The legislation F2019L01136 pertains to amendments in the Australia New Zealand Food Standards Code, specifically concerning the use of rebaudioside D (Reb D) produced via an enzymatic conversion method and the specific enzyme used in its production. This Act applies to Food Standards Australia New Zealand (FSANZ), which is tasked with developing food standards and variations under the Food Standards Australia New Zealand Act 1991. The application for this amendment was considered and approved in accordance with the procedures outlined in Division 1 of Part 3 of the FSANZ Act. The amendment allows for the use of Reb D produced by the specified enzymatic method as a food additive, and the specific enzyme used in its production as a processing aid, subject to existing conditions and limits set out in the Code. The geographic and jurisdictional reach of this Act is within Australia and New Zealand as both countries are parties to the Food Standards Australia New Zealand Act 1991. The Act does not incorporate any documents by reference, and while public consultation was conducted, a Regulation Impact Statement was not deemed necessary due to the minor impact of the proposed variations on business and individuals. The Act also exempts itself 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.
Key Provisions
The primary sections of this legislation involve the amendment of Schedule 3 and Schedule 18 of the Australia New Zealand Food Standards Code. Specifically, section (1) introduces a new specification for rebaudioside D (Reb D) produced through a particular enzymatic conversion method into Schedule 3 (subsection S3—35(2)(c)). This amendment allows the use of Reb D produced by this method as a food additive, in compliance with existing permissions and limits for steviol glycosides in the Code. Section (2), on the other hand, amends Schedule 18 to permit the use of a specific enzyme as a processing aid in the production of Reb D, subject to the condition that its use adheres to Good Manufacturing Practice.
The obligations imposed by this Act on the relevant parties, primarily Food Standards Australia New Zealand (FSANZ), include accepting and considering applications for the development or variation of food regulatory measures, as outlined in Division 1 of Part 3 of the FSANZ Act. FSANZ must also undertake a process of public consultation, publish notices about the draft variations, and ensure the amendments comply with the Code's standards. Additionally, FSANZ is tasked with ensuring that any enzyme used as a processing aid must meet the maximum permitted amount as per Good Manufacturing Practice.
Failure to comply with the provisions of this legislation may result in civil or criminal penalties. While the specific penalties are not detailed in the explanatory statement, breaches of food standards or regulations typically incur fines, corrective actions, or, in severe cases, prosecution. The severity of the penalty often depends on the nature and extent of the breach, with higher penalties for deliberate or negligent actions that endanger public health.
The legislation is clear in its intent to regulate the use of specific enzymatic conversion methods for Reb D production and the use of certain enzymes as processing aids. By amending the Food Standards Code, it sets forth the permissible methods and conditions under which these substances can be used in food production, ensuring they meet safety and quality standards. The Authority’s role in overseeing these amendments and ensuring compliance underscores the importance of maintaining high standards in food regulation to protect public health.