EXPLANATORY STATEMENT
Food Standards Australia New Zealand Act 1991
Food Standards (Application A1318 – Steviol glycosides produced by enzymatic conversion using enzymes produced by GM Escherichia coli BL21) Variation
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 A1318 which seeks to permit the use of a combination of new enzymes sourced from genetically modified Escherichia coli BL21 as processing aids for the bioconversion of the steviol glycoside rebaudioside M, and the inclusion of a new specification that would permit the applicant’s specific enzymatic conversion method. The Authority assessed the Application in accordance with Division 1 of Part 3 and prepared a draft variation - the Food Standards (Application A1318 – Steviol glycosides produced by enzymatic conversion using enzymes produced by GM Escherichia coli BL21) Variation (the approved draft variation)
2. Variation is a legislative instrument
The approved draft variation is a legislative instrument for the purposes of the Legislation Act 2003 (see section 94 of the FSANZ Act) and be publicly available on the Federal Register of Legislation (www.legislation.gov.au).
This instrument is not subject to the disallowance or sunsetting provisions of the Legislation Act 2003. Subsections 44(1) and 54(1) of that Act provide that a legislative instrument is not disallowable or subject to sunsetting if the enabling legislation for the instrument (in this case, the FSANZ Act): (a) facilitates the establishment or operation of an intergovernmental scheme involving the Commonwealth and one or more States; and (b) authorises the instrument to be made for the purposes of the scheme. Regulation 11 of the Legislation (Exemptions and other Matters) Regulation 2015 also exempts from sunsetting legislative instruments a primary purpose of which is to give effect to an international obligation of Australia.
The FSANZ Act gives effect to an intergovernmental agreement (the Food Regulation Agreement) and facilitates the establishment or operation of an intergovernmental scheme (national uniform food regulation). That Act also gives effect to Australia’s obligations under an international agreement between Australia and New Zealand. For these purposes, the Act establishes the Authority to develop food standards for consideration and endorsement by the Food Ministers Meeting (FMM). The FMM is established under the Food Regulation Agreement and the international agreement between Australia and New Zealand, and consists of New Zealand, Commonwealth and State/Territory members. If endorsed by the FMM, the food standards on gazettal and registration are incorporated into and become part of Commonwealth, State and Territory and New Zealand food laws. These standards or instruments are then administered, applied and enforced by these jurisdictions’ regulators as part of those food laws.
3. Purpose
The purpose of the approved draft variation is to amend the Code to permit the use of a combination of new enzymes sourced from genetically modified Escherichia coli BL21 as processing aids for bioconversion of the steviol glycoside rebaudioside M. The approved draft variation amends section S3—35 and the table to subsection S18—9(3) for this purpose.
4. Documents incorporated by reference
The approved draft variation does not incorporate any documents by reference.
However, existing provisions of the Code incorporate documents by reference that would prescribe identity and purity specifications for the processing aids and food additive (the steviol glycoside rebaudioside M produced by enzymatic conversion) permitted by the approved draft variation. Section 1.1.1—15 of the Code requires substances used as processing aids and food additives to comply with any relevant identity and purity specifications listed in Schedule 3 of the Code. Subsection S3—2(1) incorporates by reference primary source specifications listed in the following: Joint FAO/WHO Expert Committee on Food Additives (JECFA) Combined Compendium of Food Additive Specifications (FAO 2021), the United States Pharmacopeial Convention (FCC 2022), Food Chemicals Codex (13th edition); and the Commission Regulation (EU) No 231/2012. These include general specifications for the identity and purity parameters of food additives and enzyme preparations used as processing aids in the production of those additives.
5. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1318 included one round of public consultation following an assessment and the preparation of a draft variation and an associated assessment summary. A call for submissions (including the draft variation) was open for a six-week period.
Further details of the consultation process, the issues raised during consultation and by whom, and the Authority’s response to these issues are available in an approval report published on the Authority’s website at www.foodstandards.gov.au.
Changes have been made to the impact analysis requirements by the Office of Impact Analysis (OIA) [1]. Impact analysis is no longer required to be finalised with the OIA. Under the new approach to impact analysis, FSANZ will assess whether an application requires a Regulatory Impact Statement (RIS).
FSANZ’s assessment is that a RIS is not required for this application. Prior to the abovementioned changes, the OIA advised FSANZ that a RIS was not required for applications relating to food additives. This is because applications relating to permitting the use of food additives that have been determined to be safe are considered to be minor and/or deregulatory in nature, as their use will be voluntary if the draft variation concerned is approved.
FSANZ’s decision not to develop a RIS for application A1318 is consistent with the OIA’s prior advice.
6. 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 44 of the Legislation Act 2003.
7. Variation
References to ‘variation’ in this section are references to the approved draft variation.
Clause 1 of the variation provides that the name of the variation is the Food Standards (Application A1318 – Steviol glycosides produced by enzymatic conversion using enzymes produced by GM Escherichia coli BL21) Variation.
Clause 2 of the variation provides that the Code is amended by the Schedule to the variation.
Clause 3 of the variation provides that the variation will commence on the date of gazettal of the instrument.
7.1 Item [1]
Item [1] of the Schedule to the variation amends Schedule 3 by repealing subparagraph S3—35(2)(f)(ii) and replacing it with:
- the current subparagraph S3—35(2)(f)(ii); and
- a new entry, as paragraph S3—35(2)(g), for the enzymatic conversion of purified stevia leaf extract to produce rebaudioside M using a combination of the following enzymes:
- UDP-glucosyltransferase from Stevia rebaudiana sourced from Escherichia coli BL21, and
- sucrose synthase (EC 2.4.1.13) from Arabidopsis thaliana sourced from Escherichia coli BL21.
7.2 Item [2]
Item [2] of the Schedule to the variation amends Schedule 18 by including two enzyme listings in the table to subsection S18—9(3), which lists substances permitted to be used as processing aids for specific technological purposes.
The following enzymes are listed in alphabetical order in column 1 of the table:
- Sucrose synthase (EC 2.4.1.13) sourced from Escherichia coli BL21 containing the gene for sucrose synthase from Arabidopsis thaliana
- Uridine diphosphate (UDP) glucosyltransferases sourced from Escherichia coli BL21 containing the UDP glucosyltransferase gene from Stevia rebaudiana
The specific technological purpose for each enzyme is prescribed in column 2 of the table for the corresponding enzyme i.e. ‘for the conversion of purified stevia leaf extract to produce rebaudioside M’.
The maximum permitted level (MPL) at which each enzyme may be present in food is prescribed in column 3 of the table for the corresponding enzyme. That is, the MPL must be consistent with Good Manufacturing Practice (as defined by subsection 1.1.2—2(3) of the Code).
The effect of the amendments made by Items [1] and [2] above is to permit the use of an enzymatic conversion method of producing the steviol glycoside rebaudioside M which uses a combination of enzymes that contains both:
- UDP-glucosyltransferases from Stevia rebaudiana sourced from Escherichia coli BL21, and
- sucrose synthase (EC 2.4.1.13) from Arabidopsis thaliana sourced from Escherichia coli BL21.
[1] Formerly known as the Office of Best Practice Regulation (OBPR)