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 A1222 which sought an amendment to the Code to permit the use of a steviol glycosides mixture (primarily consisting of rebaudioside M with lesser amounts of rebaudioside D, that may contain minor amounts of other steviol glycosides), produced by fermentation of simple sugars using a genetically modified Yarrowia lipolytica strain, as an intense sweetener (food additive). The steviol glycosides mixture is produced for use as a food additive in the form of a steviol glycosides preparation. The Authority considered the application in accordance with Division 1 of Part 3 of the FSANZ Act 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 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 amending section S3—39 to include a new source of steviol glycosides—the applicant’s Yarrowia lipolytica strain VRM0014 containing novel genes for the production of steviol glycosides, in the list of steviol glycosides sources set out in this section. A steviol glycosides preparation to which section S3—39 applies contains steviol glycosides that are only derived from one of the listed sources.
Section S3—39 sets out the identity and purity specifications for steviol glycosides preparations obtained from fermentation, not from the leaves of the Stevia rebaudiana Bertoni plant.
The effect of these amendments is that the specifications in section S3—39 for steviol glycosides preparations obtained from fermentation apply to the applicant’s steviol glycosides preparation.
The above amendments permit the applicant’s steviol glycosides preparation to be used as a food additive (intense sweetener) in a food for sale. Use of this steviol glycosides preparation as a food additive must be in accordance with the Code’s existing permissions and limits for steviol glycosides, including the requirement that the preparation complies with the specifications set out in section S3—39.
3. Documents incorporated by reference
The variation in this instrument does not incorporate any documents by reference.
However, the instrument will vary Schedule 3 of the Code which does incorporate documents by reference. Section 1.1.1—15 of the Code requires certain substances (such as food additives) to comply with any relevant identity and purity specifications listed in Schedule 3. Schedule 3 incorporates documents by reference to set specifications for various substances in the circumstances specified in that Schedule. The documents incorporated include: the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Compendium of Food Additive Specifications (FAO/WHO 2017); the United States Pharmacopeial Convention (2018) Food Chemicals Codex (11th edition); and the Commission Regulation (EU) No 231/2012.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of application A1222 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 11 June 2021 for a six-week consultation period.
The Office of Best Practice Regulation (OBPR) granted the Authority a standing exemption from needing to develop a Regulatory Impact Statement for proposed variations of the Code to permit food additives (OBPR correspondence dated 24 November 2010 - reference 12065). This standing exemption was provided as permitting additional food additives is machinery in nature as it is part of implementing a regulatory framework where the use of the new additive is voluntary once the application has been successfully approved. It is a minor, deregulatory change that allows for the introduction of a new version of a food additive to the food supply that has been determined to be safe.
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 draft variation sets out two amendments to Schedule 3.
Sub-item [1.1] amends Schedule 3 by omitting existing subsections S3—39(1) and (2), and replacing them with a revised subsection (1).
Revised subsection S3—39(1) states that the specification in this section relates to a steviol glycosides preparation that meets all of the following conditions—the preparation:
(a) is obtained from fermentation; and
(b) is not obtained from the leaves of the Stevia rebaudiana Bertoni plant; and
(c) contains steviol glycosides that are only derived from one of the following:
(i) Saccharomyces cerevisiae strain CD15407 containing novel genes for the production of steviol glycosides;
(ii) Saccharomyces cerevisiae strain Y63348 containing novel genes for the production of steviol glycosides;
(iii) Yarrowia lipolytica strain VRM0014 containing novel genes for the production of steviol glycosides.
Revised subsection S3—39(1) includes a reference to a new source of steviol glycosides i.e. steviol glycosides derived from Yarrowia lipolytica strain VRM0014 containing novel genes for the production of steviol glycosides.
Consequently, the specifications set out in section S3—39 also apply to a steviol glycoside preparation containing steviol glycosides (which under A1222 are primarily rebaudioside M, with lesser amounts of rebaudioside D, and possibly other steviol glycosides) derived from this new source.
Sub-item [1.2] amends Schedule 3 by renumbering subsection S3—39(3) as ‘S3—39(2)’, as a consequence of the amendment in sub-item [1.1] above.
The consequential effect of these amendments is to permit the following steviol glycoside preparation to be used as a food additive (intense sweetener)–a preparation that:
- is obtained by fermentation (not from the leaves of the Stevia rebaudiana Bertoni plant); and
- contains the steviol glycosides—rebaudiosides M and D (and possibly other steviol glycosides), derived from Yarrowia lipolytica strain VRM0014.
Use of this steviol glycoside preparation as a food additive must be in accordance with the Code’s existing permissions and limits for steviol glycosides, including the requirement that the preparation complies with the specifications set out in section S3—39.