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 A1157 which sought an amendment to Schedule 3 of the Code to prescribe a new specification for rebaudioside M (Reb M) produced by a particular enzymatic conversion method. The Authority considered the application in accordance with Division 1 of Part 3 and has approved 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 draft variation of a standard.
2. Purpose
The purpose of the variations is to permit the use as a food additive of Reb M produced using the enzymatic conversion method detailed in Application A1157. To this end, the variations amends the specification for Reb M provided by S3—35(2) of Schedule 3 of the Code by inserting a reference to that enzymatic conversion method. The variations also amend Schedule 18 of the Code to permit the use as processing aids of the specific enzymes used in that enzymatic conversion method. The effect of the variations is to permit the use of Reb M produced by that method to be used as a food additive in accordance with the existing permissions and limits for steviol glycosides (including containing Reb M) in 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 A1157 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 20 July 2018 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variations 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 omits S3—35(2) and substitutes new subsection S3—35(2) and (2A).
The new subsection S3—35(2) includes a reference to the enzymatic conversion of purified stevia leaf extract to produce Reb M using protein engineered enzymes that: contain both UDP‑glucosyltransferase (EC 2.4.1.17) and sucrose synthase (EC 2.4.1.13) components; and are sourced from both of the following; a Pichia pastoris strain expressing UGT-A, and a Pichia pastoris strain expressing both UGT-B1 and UGT-B2.
The new subsection S3—35(2A) restates the proviso in the current subsection S3—35(2) that the final product may be spray dried.
The effect of this amendment is to permit Reb M 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 containing Reb M).
Item [2]
Item [2] amends Schedule 18. The item inserts a new entry into the table to subsection S18—9(3). The effect of the new entry would be to permit the use of specific enzymes as a processing aid in the manufacture of Reb M for the following technological purpose: the conversion of purified stevia leaf extract to produce Reb M. The permitted enzymes are protein engineered enzymes that: contain both UDP‑glucosyltransferase (EC 2.4.1.17) and sucrose synthase (EC 2.4.1.13) components; and are sourced from both of the following; a Pichia pastoris strain expressing UGT-A, and a Pichia pastoris strain expressing both UGT-B1 and UGT-B2. 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 F2019L00039 legislation, enacted under the Food Standards Australia New Zealand Act 1991, addresses the need to update food additive standards within the Australia New Zealand Food Standards Code. Specifically, it aims to permit the use of rebaudioside M (Reb M) produced by a particular enzymatic conversion method as a food additive. This legislative action was taken in response to Application A1157, which sought to amend the specifications for Reb M and the permitted enzymes used in its production. The Authority, in accordance with the FSANZ Act, considered the application, conducted a round of public consultation, and approved the draft variation. The objective of these variations is to allow the use of Reb M produced through this enzymatic method, thereby aligning with existing permissions and limits for steviol glycosides in the Code. The enactment ensures that these changes are publicly communicated and subject to ministerial oversight, reflecting the policy of maintaining food safety and quality standards in Australia and New Zealand.
Scope and Application
The F2019L00039 instrument amends the Australia New Zealand Food Standards Code by permitting the use of rebaudioside M (Reb M) produced through a particular enzymatic conversion method as a food additive. This legislation applies to food industry entities and individuals who manufacture or use food additives, specifically those involved in the production and use of Reb M derived from enzymatic conversion processes. The amendments to the Food Standards Code, administered by Food Standards Australia New Zealand (FSANZ), are in line with the procedures outlined in the Food Standards Australia New Zealand Act 1991. This Act encompasses the Commonwealth jurisdiction, thereby extending its reach across both Australia and New Zealand. The variations do not incorporate any documents by reference and are exempt from the requirement for a statement of compatibility with human rights as they are non-disallowable instruments. The changes are expected to have a minor impact on businesses and individuals, as indicated by the absence of a Regulation Impact Statement. The Authority has completed one round of public consultation in line with the procedural requirements of the FSANZ Act. The legislative instrument does not specify any exclusions or exemptions but may be further refined or restricted through subordinate instruments as deemed necessary by FSANZ.
Key Provisions
The legislation under review primarily focuses on amending the Australia New Zealand Food Standards Code to permit the use of rebaudioside M (Reb M) produced by a specific enzymatic conversion method as a food additive. This is accomplished through variations to Schedule 3 and Schedule 18 of the Code. The key operative sections involved in these variations are detailed in Items [1] and [2], which respectively amend the specifications for Reb M and permit the use of specific enzymes as processing aids. These variations are introduced to align with the enzymatic conversion method described in Application A1157, allowing the use of Reb M produced by this method in accordance with existing food additive permissions in the Code.
The obligations imposed by the Act on the parties involved are primarily centred around the acceptance and consideration of the application A1157 by Food Standards Australia New Zealand (the Authority). The Authority is required to follow the procedure outlined in Division 1 of Part 3 of the FSANZ Act, which includes a round of public consultation following an assessment and the preparation of a draft Standard and associated assessment summary. Furthermore, the Authority must publish a notice about the draft variation as stipulated in section 92 of the FSANZ Act. This ensures transparency and allows for public input on the proposed variations.
In terms of civil or criminal consequences for breach, the explanatory statement does not detail specific offences or penalties. However, under the FSANZ Act, non-compliance with food standards and regulations can lead to enforcement actions, which may include fines, corrective notices, or other legal remedies. The maximum penalties for breaches of the Act can vary depending on the nature and severity of the offence but may include substantial fines for individuals and corporations.
Additionally, the legislation stipulates that the variations do not incorporate any documents by reference, ensuring clarity and direct application of the standards. The consultation process is designed to be thorough yet efficient, with a six-week period for submissions following the assessment and draft preparation. Given the minor impact of the proposed variations on business and individuals, a Regulation Impact Statement was deemed unnecessary. Finally, as the instrument is a non-disallowable one under section 94 of the FSANZ Act, it is exempt from the requirements for a statement of compatibility with human rights.