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 A1207 which sought an amendment to the Code to permit the use of rebaudioside M (Reb M) produced from fermentation by a genetically modified Saccharomyces cerevisiae (S. cerevisiae) strain, as a food additive intense sweetener. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation.
Following consideration by the Food Ministers’ Meeting (formerly the Australia and New Zealand Ministerial Forum on Food Regulation)[1], 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 to the table to subsection S3—39(2) of the Code to permit Reb M to be used as a food additive (an intense sweetener) in accordance with the Code.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
Existing provisions of the Code incorporate a document by reference that will prescribe identity and purity specifications for the food additive to be permitted by the draft variation. Section 1.1.1—15 of the Code requires substances used as food additives to comply with any relevant identity and purity specifications listed in Schedule 3 of the Code. Section S3—2 of Schedule 3 incorporates by reference the specifications listed in 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, specifications for food additives. These include specifications for this food additive.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of application A1207 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 21 October 2020 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 (including new methods of manufacture of existing food additives) is likely to have only a minor impact on business and individuals. 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. The use of the approved food additive is also voluntary.
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 inserts a new entry into the table to subsection S3—39(2), which lists ‘prescribed steviol glycosides’ for the purposes of specifications in subsection S3—39(3).
The new entry is ‘Rebaudioside M’ derived from ‘Saccharomyces cerevisiae strain Y63348 containing novel genes for the production of rebaudiosides’. In other words, Reb M derived from this source will be a prescribed steviol glycoside and specifications in subsection S3—39(3) will apply to this Reb M.
The effect of this amendment will be to permit Reb M that is derived from this source, obtained by fermentation, and not from the leaves of the Stevia rebaudiana Bertoni plant, to be used as a food additive in accordance with the existing food additive permissions in the Code for steviol glycosides, provided that the Reb M complies with the specifications listed in subsection S3—39(3).
[1] The Forum name change took effect on 21 February 2021 following a decision by Ministers.
Overview
The Food Standards Australia New Zealand Act 1991 was enacted to ensure that food standards set by Food Standards Australia New Zealand (FSANZ) are based on scientific evidence and promote public health and safety. This legislation established FSANZ as the bi-national agency responsible for developing and maintaining the Australia New Zealand Food Standards Code. The Authority, under this Act, is empowered to develop, vary, and amend standards and to consider applications for food regulatory measures, including standards. The explanatory statement outlines the Authority's approval of a draft variation to permit rebaudioside M (Reb M), produced by fermentation from a genetically modified Saccharomyces cerevisiae strain, as a food additive intense sweetener. This amendment addresses the gap in the food additive provisions by introducing a new source of Reb M, distinct from the traditional Stevia rebaudiana Bertoni plant, thereby expanding the range of approved food additives. The Authority followed the procedure outlined in Division 1 of Part 3 of the FSANZ Act, including public consultation, before approving the draft variation. This amendment aims to ensure that any new food additives introduced into the food supply are safe and comply with the existing regulatory framework.
Scope and Application
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) provides the legislative framework for the development, variation and enforcement of food standards across Australia and New Zealand. Pursuant to the FSANZ Act, Food Standards Australia New Zealand (FSANZ) has approved a draft variation to the Australia New Zealand Food Standards Code to permit the use of rebaudioside M (Reb M) produced from fermentation by a genetically modified Saccharomyces cerevisiae strain as a food additive intense sweetener. The variation applies to Reb M derived from this specific genetically modified source, which is distinct from Reb M obtained from the leaves of the Stevia rebaudiana Bertoni plant. The variation allows Reb M derived from fermentation to be used as a food additive, subject to compliance with the relevant identity and purity specifications. The variation does not incorporate any documents by reference but refers to existing specifications incorporated in the Code. The variation follows a public consultation process and is exempt from requiring a Regulatory Impact Statement. The variation is a legislative instrument but is not subject to parliamentary disallowance or sunsetting. The variation will permit the use of a new source of Reb M as a food additive, provided it meets the necessary safety and quality standards.
Key Provisions
The main sections of this legislation involve the approval and amendment of food standards in Australia, specifically relating to the use of rebaudioside M (Reb M) as a food additive. Section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) outlines the Authority's role in developing standards and variations for the Australia New Zealand Food Standards Code (the Code). Division 1 of Part 3 of the FSANZ Act provides the procedure for considering applications for the development or variation of food regulatory measures, including standards. Section 92 mandates the publication of a notice about the standard or draft variation, and section 94 specifies that such standards or variations are legislative instruments but are not subject to parliamentary disallowance or sunsetting.
The Act imposes several obligations on the Authority and other entities it governs. The Authority must accept applications for the development or variation of food regulatory measures and consider them in accordance with the procedures outlined in Division 1 of Part 3 of the FSANZ Act. After considering an application and preparing a draft variation and associated report, the Authority must publish a notice about the draft variation, as per section 92 of the FSANZ Act. Public consultation is also required, although for minor variations like this one, a Regulatory Impact Statement is not necessary due to a standing exemption granted by the Office of Best Practice Regulation (OBPR).
The legislation also specifies that any approved variations are not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003, as per section 94. This means that once the variation is approved and published, it will become part of the Code without needing further legislative approval. Furthermore, the Authority must ensure that any substances used as food additives comply with relevant identity and purity specifications, as per section 1.1.1—15 of the Code.
The consequences of breaching the provisions of this legislation are primarily civil in nature. While the explanatory statement does not detail specific criminal penalties, the failure to comply with food standards could result in civil penalties under the FSANZ Act. Such penalties might include fines or other enforcement actions taken by regulatory authorities to ensure compliance with food safety standards. Additionally, any breaches of the Code or non-compliance with the approved specifications for food additives could result in legal action or administrative penalties.
In summary, this legislation outlines the process for approving variations to food standards, specifically permitting the use of Reb M derived from a genetically modified S. cerevisiae strain as a food additive. The Authority has a duty to consider applications, consult the public, and publish notices as required. Compliance with the Code and the approved specifications is mandatory, and breaches could lead to civil penalties or other enforcement actions.