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 A1183 which seeks approval for a new specification for the steviol glycoside rebaudioside E produced by an enzymatic conversion method using a processing aid derived from a genetically modified strain of Pichia pastoris. 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.
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:
- permit steviol glycoside preparations containing rebaudioside E produced by the new enzymatic conversion method to be used as a food additive in accordance with the existing permissions and limits for steviol glycosides in the Code; and
b. permit a particular substance to be used as a processing aid in the manufacture of the A1183 applicant’s rebaudioside E preparation 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 A1183 included one round of public consultation following an assessment and the preparation of a draft variation and associated report.
A Regulation Impact Statement was not required because the proposed 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]
Item [1] amends section S3—35 of the Code which sets out the specification for steviol glycosides from Stevia rebaudiana Bertoni.
In particular, subsection S3—35(2) is amended by omitting subparagraph S3—35(2)(d)(iii) and inserting in its place amended subparagraph S3—35(2)(d)(iii) and new paragraph S3—35(2)(e).
Paragraph S3—35(2)(d) was inserted into the Code by the variation for Application A1176, which came into force on 26 February 2020. The amendment made by item [1] changes the punctuation at the end of that paragraph to reflect the addition of new paragraph S3—35(2)(e).
New paragraph S3—35(2)(e) specifies the following process by which a steviol glycosides preparation can be obtained from the leaves of the Stevia rebaudiana Bertoni plant—the enzymatic conversion of purified stevia leaf extract to produce rebaudioside E using a protein engineered enzyme that: contains both uridine diphosphate (UDP) glucosyltransferase and sucrose synthase (EC 2.4.1.13); and is sourced from Pichia pastoris (strain UGT-A).
6.2 Item [2]
Item [2] amends Schedule 18 by inserting a new entry into the table to subsection S18—9(3). This table lists permitted substances that may be used as processing aids for specific technological purposes.
The new entry lists a protein engineered enzyme containing both of the following components: UDP‑glucosyltransferase and sucrose synthase (EC 2.4.1.13); and which is sourced from Pichia pastoris strain UGT-A.
The specified technological purpose for this protein engineered enzyme processing aid is the conversion of purified stevia leaf extract to produce rebaudioside E.
The maximum permitted level at which the enzyme may be present in food must be consistent with Good Manufacturing Practice (as defined by section 1.1.2—2(3) of the Code).
The cumulative effect of the amendments in items [1] and [2] above is to permit the following substance to be used as a food additive (in accordance with the existing relevant permissions in the Code): a steviol glycoside preparation containing rebaudioside E produced by the enzymatic conversion of purified stevia leaf extract using the above protein engineered enzyme as a processing aid.