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 A1176 which seeks approval for a new specification for steviol glycosides produced by an enzymatic conversion method using enzymes derived from genetically modified strains of Escherichia coli (E. coli). The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft variation to amend the Code.
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 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 approved a draft variation to:
- amend subsection S3—35(2) of the Code by including, in the specification for steviol glycosides from Stevia rebaudiana Bertoni, a reference to the enzymatic conversion method used to produce the following steviol glycosides: rebaudiosides D, M and AM, thereby permitting such steviol glycosides to be used as food additives in accordance with the existing permissions and limits for steviol glycosides in the Code; and
- amend Schedule 18 of the Code to permit the use of the specific enzymes as processing aids in the production of rebaudiosides D, M and AM 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 A1176 included one round of public consultation following an assessment and the preparation of a draft variation and associated assessment summary. Submissions were called for on 27 August 2019 for a six-week consultation period.
A Regulation Impact Statement was not required because the approved variations to Schedules 3 and 18 are likely to have a minor impact on business and individuals (OBPR reference 12065).
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
6.1 Item [1.1]
Item [1.1] amends Schedule 3 of the Code by omitting subsection S3—35(1) and inserting, in its place, new subsections S3—35(1) and S3—35(1A).
New subsection S3—35(1) provides a definition of the terms ‘prescribed rebaudiosides’ and ‘rebaudioside AM’ for the purposes of section S3—35, particularly paragraph S3—5(2)(d) as provided by item [1.2] below.
New subsection S3—35(1A) simply restates the current section S3—35(1).
6.2 Item [1.2]
Item [1.2] adds a new paragraph (d) to subsection S3—35(2) of Schedule 3 of the Code.
The item does this by omitting paragraph S3—35(2)(c) and inserting in its place new paragraphs S3—35(2)(c) and (d).
Paragraph S3—35(2)(c) was inserted into the Code by the draft variation approved by FSANZ for Application A1172, which took effect prior to this draft variation approved for Application A1176.
Item [1.2] restates and does not amend paragraph S3—35(2)(c).
The new paragraph S3—35(2)(d) includes a reference to the enzymatic conversion of purified stevia leaf extract to produce rebaudiosides D, M and/or AM. The enzymatic conversion processes uses the following combination of enzymes:
- a uridine diphosphate (UDP) glucosyltransferase from Stevia rebaudiana sourced from Escherichia coli
- a UDP-glucosyltransferase from Solanum lycopersicum sourced from Escherichia coli
- a sucrose synthase (EC 2.4.1.13) sourced from Escherichia coli.
The effect of this amendment is to permit the following steviol glycosides: rebaudiosides D, M and/or AM, produced using this method, to be used as food additives in accordance with the existing food additive permissions in the Code for steviol glycosides.
6.3 Item [1.3]
Item [1.3] amends the requirement for steviol glycoside preparations obtained from the leaves of the Stevia rebaudiana Bertoni plant from 200 to 300 times sweeter than sucrose to 150 to 300 times sweeter than sucrose.
6.4 Item [2]
Item [2] amends Schedule 18 by inserting new entries into the table to subsection S18—9(3).
The effect of the new entries is to permit the use of specific enzymes as processing aids for the following technological purpose - the conversion of purified stevia leaf extract to produce one or more of the following: rebaudioside D, rebaudioside M; and rebaudioside AM. The permitted enzymes are:
- Sucrose synthase (EC 2.4.1.13) sourced from Escherichia coli K-12 containing the gene for sucrose synthase from Arabidopsis thaliana
- Uridine diphosphate (UDP) glucosyltransferase sourced from Escherichia coli K-12 containing the UDP glucosyltransferase gene from Solanum lycopersicum
- UDP glucosyltransferase sourced from Escherichia coli K-12 containing the UDP glucosyltransferase gene from Stevia rebaudiana.
The permissions include the condition that the maximum permitted amount used as a processing aid must be consistent with Good Manufacturing Practice (GMP) (as defined by section 1.1.2—2(3) of the Code).