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.
FSANZ accepted Application A1123 which sought to permit isomalto-oligosaccharide as a novel food, to be used as an alternative sweetener and bulk filler in a range of foods. 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 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
Isomalto-oligosaccharide is currently not permitted under the Code. The Authority has approved a draft variation that will amend the table to section S25—2 to permit IMO to be used in in food offered for retail sale other than infant formula products, infant food and formulated supplementary foods for young children. The variation will also amend Schedule 3 to provide specifications for IMO’s identity and purity.
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 A1123 included one round of public consultation following an assessment and the preparation of a draft variation and associated reports. Submissions were called for on 13 December 2016 for an eight-week consultation period.
A Regulation Impact Statement was not required because the variations to Schedules 3 and 25 are deemed to be deregulatory in nature (see OBPR ID 20966) and 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
6.1 Schedule 3
Subitem [1.1] amends the table to subsection S3—2(2) by inserting references to isomalto-oligosaccharide and section S3—37.
Subitem [1.2] inserts new section S3—37. The proposed subsection sets specifications for isomalto-oligosaccharide’s identity and purity for the purposes of section 1.1.1—15 of the Code.
6.2 Schedule 25
Item 2 inserts a reference to and conditions of use for isomalto-oligosaccharide into the table to section S25—2. The effect of the amendment is to provide a permission for isomalto-oligosaccharide as a novel food in food offered for retail sale for the purposes of section 1.1.1—10 of the Code. The permission is for food (other than infant formula products, food for infants and formulated supplementary food for young children) to consist of isomalto-oligosaccharide or have isomalto-oligosaccharide as an ingredient. The conditions prohibit the addition of isomalto-oligosaccharide to infant formula products (Standard 2.9.1), food for infants (Standard 2.9.2) and formulated supplementary food for young children (Standard 2.9.3, Division 4).
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) is the legislative framework that empowers Food Standards Australia New Zealand (FSANZ) to develop and vary food standards, including approving the use of novel foods such as isomalto-oligosaccharide (IMO). Enacted by the Australian Parliament, the Act aims to ensure that food standards are science-based, consumer-focused, and consistent with international obligations. The legislative instrument F2017L00915 was introduced to address the gap in the existing food standards by permitting the use of IMO as an alternative sweetener and bulk filler in a range of foods, excluding infant formula products, infant food, and formulated supplementary foods for young children. The Authority conducted a public consultation as per the procedural requirements set out in the FSANZ Act and approved the draft variation, which includes specifications for IMO's identity and purity. This legislative instrument does not require a Regulation Impact Statement as it is considered deregulatory and of minor impact.
Scope and Application
The proposed legislative instrument under the Food Standards Australia New Zealand Act 1991 pertains to the approval of a draft variation permitting the use of isomalto-oligosaccharide (IMO) as a novel food in various food products, excluding infant formula, infant food, and formulated supplementary foods for young children. The Authority has followed the stipulated procedure for considering an application for the development or variation of food regulatory measures as per Division 1 of Part 3 of the FSANZ Act. The Authority’s decision to permit IMO follows a round of public consultation and is in line with the regulatory framework for food standards in Australia and New Zealand. The legislative instrument amends Schedule 3 to include specifications for IMO's identity and purity, and Schedule 25 to allow for the use of IMO in foods offered for retail sale under specific conditions. This variation does not incorporate any documents by reference and is exempt from the requirements for a statement of compatibility with human rights, being a non-disallowable instrument under section 94 of the FSANZ Act.
Key Provisions
The key provisions of the legislation concern the approval of a draft variation to permit isomalto-oligosaccharide (IMO) as a novel food for use as an alternative sweetener and bulk filler in certain foods. This variation is being implemented under the Food Standards Australia New Zealand Act 1991 (FSANZ Act). According to section 13 of the FSANZ Act, Food Standards Australia New Zealand (the Authority) is responsible for developing standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code (the Code). Under section 92, the Authority must publish a notice about the standard or draft variation of a standard, while section 94 specifies that such a standard, or a variation of a standard, is a legislative instrument but is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003.
The approved draft variation seeks to amend the Code to permit IMO in food offered for retail sale, with the exception of infant formula products, infant food, and formulated supplementary foods for young children. This is achieved through amendments to Schedule 3 to provide specifications for IMO’s identity and purity and through amendments to Schedule 25 to include a reference to and conditions of use for IMO. These amendments will allow the use of IMO in certain foods while prohibiting its addition to infant formula products, food for infants, and formulated supplementary food for young children.
The legislation imposes certain obligations on the Authority and potentially on businesses that intend to use IMO in their products. The Authority must follow the procedure outlined in Division 1 of Part 3 of the FSANZ Act, which includes accepting applications for the development or variation of food regulatory measures, such as the approval of IMO as a novel food. The Authority also must conduct public consultation as part of this process, which was carried out for Application A1123 with submissions called for on 13 December 2016 for an eight-week period. Businesses that intend to use IMO in their products must ensure compliance with the new specifications and conditions outlined in the Code.
Breach of the new standards and variations may lead to civil or criminal consequences, depending on the nature and severity of the violation. While the explanatory statement does not specify penalties, under the FSANZ Act, breaches of food standards can result in significant penalties. For example, under section 44 of the FSANZ Act, a corporation can be fined up to $1.2 million for a serious breach and up to $66,000 for a minor breach. Individuals responsible for the breach can also face personal penalties. It is essential for businesses to adhere to the new standards to avoid potential legal repercussions.