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 A1170 which sought approval for a steviol glycoside mixture (Reb MD) for use as an intense sweetener, produced from a GM Saccharomyces cerevisiae. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft Standard.
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.
2. Purpose
The Authority has approved a draft variation to insert new subsection S3—39 into Schedule 3 of the Code to permit Reb MD produced from fermentation to be used as a food additive in accordance with the Code’s existing permissions and limits for steviol glycosides (including for steviol glycosides containing Reb MD).
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 A1170 included one round of public consultation following an assessment and the preparation of a draft Standard and associated report. Submissions were called for on 2 April 2019 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variations to Schedule 3 are likely to have a minor impact on business and individuals.
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] varies Schedule 3.
Item [1.1] varies the table to subsection S3—2(2). The variation amends that table to include in it references to ‘steviol glycosides from fermentation’ and to new section S3—39. The effect is that subsection 1.1.1—15(2) of Standard 1.1.1 will require a steviol glycosides preparation obtained from fermentation and that meets the criteria listed in subsection S3—39(1) to comply with the specifications listed in subsection S3—39(3) when that preparation is added to food or sold for use in food,
Item [1.2] inserts new section S3—39 into Schedule 3.
Subection S3—39(1) will provide that the specifications imposed by subsection S3—39(3) will apply to a steviol glycosides preparation that: is obtained from fermentation; is not obtained from the leaves of the Stevia rebaudiana Bertoni plant; and contains a prescribed steviol glycoside.
Subsection S3—39(2) will provide a definition of the term ‘prescribed steviol glycoside’ that is used in subsection S3—39(1). The term is defined to mean rebaudioside MD derived from the following source: Saccharomyces cerevisiae strain CD15407 containing novel genes for the production of rebaudiosides.
The definition is in the form of a table in order to provide for the possibility that, in the future, other steviol glycosides may need to added to the definition of ‘prescribed steviol glycoside’.
Subsection S3—39(3) will provide the specifications. These are for: description; assay; solubility; pH; total ash; loss on drying; residual solvents; arsenic; lead; cadmium; and mercury. The subsection also provides that the final product may be spray dried.
The effect of this amendment will be to permit rebaudioside MD that is 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 rebaudioside MD complies with the specifications listed in subsection S3—39(3).
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) was enacted to establish Food Standards Australia New Zealand as the primary agency for the development and administration of food standards in Australia and New Zealand. The Act aims to protect public health and safety by ensuring that food standards are science-based, up-to-date, and reflect current knowledge. The FSANZ Act empowers the Authority to develop, vary, and administer food regulatory measures, including standards, to regulate food composition, labelling, and safety. The explanatory statement for F2019L01135 details the Authority's approval of a draft variation to permit a steviol glycoside mixture (Reb MD) produced from genetically modified Saccharomyces cerevisiae through fermentation to be used as an intense sweetener in food. This variation aims to insert new subsection S3—39 into Schedule 3 of the Australia New Zealand Food Standards Code, aligning with existing permissions and limits for steviol glycosides. The Authority conducted one round of public consultation in accordance with the FSANZ Act before approving the draft standard. This variation facilitates the use of Reb MD obtained through fermentation, provided it meets specific criteria and complies with detailed specifications regarding its composition and purity.
Scope and Application
The explanatory statement outlines the legislative framework concerning the approval of a draft variation to allow the use of Reb MD, a sweetener derived from genetically modified Saccharomyces cerevisiae, as a food additive under the Australia New Zealand Food Standards Code. The Food Standards Australia New Zealand Act 1991 (FSANZ Act) empowers the Authority to develop and vary food regulatory measures, including standards. This particular legislation applies to the Authority, entities that manufacture or supply food additives, and potentially any businesses involved in the food industry that may be affected by the new standards. The Act's reach is national, applying across both Australia and New Zealand as per the Code. The Authority has followed the statutory procedure, including a round of public consultation, and determined that the variations proposed have a minor impact on business and individuals, thus no Regulation Impact Statement was required. The instrument is exempt from human rights compatibility statements as it is a non-disallowable instrument under the FSANZ Act. The variation includes amendments to the specifications for steviol glycosides from fermentation and introduces new subsection S3—39 detailing the criteria and specifications for the use of rebaudioside MD as a food additive. The Authority’s decision to approve this draft standard will be published in accordance with the FSANZ Act.
Key Provisions
The key operative sections of this legislation pertain primarily to the approval and implementation of a draft Standard for the use of a steviol glycoside mixture (Reb MD) derived from genetically modified Saccharomyces cerevisiae as an intense sweetener. Under section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act), Food Standards Australia New Zealand (the Authority) has the function to develop and vary food standards. In this case, the Authority has approved a draft variation to insert new subsection S3—39 into Schedule 3 of the Australia New Zealand Food Standards Code (the Code). This variation aims to allow the use of Reb MD produced from fermentation as a food additive under the existing permissions and limits for steviol glycosides (section 92). This new subsection will specify the criteria and conditions under which Reb MD can be used, including a detailed list of specifications such as description, assay, solubility, and permissible levels of contaminants like arsenic, lead, cadmium, and mercury.
The Act imposes several obligations and requirements on the parties and entities it governs. The Authority must follow the procedure specified in Division 1 of Part 3 of the FSANZ Act when considering applications for the development or variation of food regulatory measures. This includes conducting a public consultation as part of the consideration process. For the draft variation in question, the Authority followed this procedure by calling for submissions on 2 April 2019 for a six-week consultation period. Additionally, the Authority is mandated to publish a notice about the draft standard or variation of a standard following its approval by the Australia and New Zealand Ministerial Forum on Food Regulation. This ensures transparency and allows stakeholders to review and comment on proposed changes to food standards.
Breaches of the provisions in this legislation can lead to various civil and criminal consequences. While specific offences and penalties are not detailed in the Explanatory Statement, violations of food standards generally can result in significant penalties under the FSANZ Act and other related legislation. For instance, if a food additive does not comply with the specifications outlined in the approved draft Standard, it could be considered unsafe and subject to enforcement actions. Penalties for such breaches can include fines and, in severe cases, imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as any relevant provisions in the FSANZ Act or other applicable laws. The legislative framework aims to ensure that food products on the market are safe and comply with the established standards to protect public health.