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 A1124 which seeks to permit the addition of DHA-rich algal oil from Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695) as an additional or alternative source of DHA oil for other currently permitted DHA-rich algal oils added to infant formula products.
The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared a draft variation setting out amendments to Schedule 3 and Schedule 25.
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 purpose of the draft variation is to permit the voluntary use of oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695) as a source of DHA in infant formula products.
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 A1124 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 1 November 2016 for a six-week consultation period.
A Regulation Impact Statement was not required because the variations proposed are voluntary 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
Subitem [1.1] amends Schedule 3 by inserting a reference into the table to subsection S3—2(2) to oil derived from marine micro-algae Schizochytrium sp. (ATCC PTA-9695) and to section S3—36.
Subitem [1.2] amends Schedule 3 by inserting new section S3—36 in that Schedule. The new section provides a specification for oil derived from marine micro-algae Schizochytrium sp. (ATCC PTA-9695).
Item [2] amends Schedule 25 by inserting a reference into the table to section S25—2 to oil derived from marine micro-algae Schizochytrium sp. (ATCC PTA-9695). The new reference contains a condition that the oil may only be added to infant formula products in accordance with Standard 2.9.1. The effect of the amendment is to provide a novel food permission for the use of the oil in only infant formula products.
Overview
The F2017L00586 legislation, enacted in 2017, addresses the need for updating food regulatory measures concerning the sources of DHA in infant formula products. This legislative instrument was introduced under the Food Standards Australia New Zealand Act 1991 (FSANZ Act), with the objective of improving food safety and nutritional standards. The Authority, Food Standards Australia New Zealand, was tasked with considering applications for the development or variation of food regulatory measures, including standards. This particular draft variation was initiated following an application to permit the use of DHA-rich algal oil from Schizochytrium sp. (ATCC PTA-9695) as an additional source of DHA in infant formula products. The Authority followed the stipulated procedure in the FSANZ Act, which includes public consultation, before preparing the draft variation. The purpose of this draft variation is to allow for the voluntary use of the specified algal oil as a source of DHA in infant formula products, thereby enhancing the nutritional profile of such products.
Scope and Application
The explanatory statement outlines the scope and application of a draft variation to the Australia New Zealand Food Standards Code concerning the addition of DHA-rich algal oil from Schizochytrium sp. (ATCC PTA-9695) as an alternative source of DHA in infant formula products. This legislative instrument applies to entities involved in the production, labelling, and sale of infant formula products within Australia and New Zealand, ensuring compliance with the updated food standards. The variation is a legislative instrument under section 94 of the Food Standards Australia New Zealand Act 1991 and is exempt from parliamentary disallowance or sunsetting. It extends the permitted sources of DHA oil in infant formula products, allowing manufacturers to incorporate oil derived from the specified marine micro-algae, subject to the conditions outlined in the new standards. Public consultation was conducted as per the procedures specified in the FSANZ Act, and the variation does not incorporate any documents by reference. The legislative instrument is non-disallowable and exempt from the requirement for a statement of compatibility with human rights.
Key Provisions
The key operative sections of this legislation, as detailed in the explanatory statement, include the acceptance of Application A1124 by the Authority under section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act). This application seeks to permit the addition of DHA-rich algal oil from Schizochytrium sp. (ATCC PTA-9695) as an additional source of DHA oil for infant formula products. The Authority has considered the application and prepared a draft variation setting out amendments to Schedule 3 and Schedule 25, which are incorporated in the legislation.
The Authority is required to publish a notice about the standard or draft variation of a standard in accordance with section 92 of the FSANZ Act. This notice is a legislative instrument but is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003 as specified in section 94 of the FSANZ Act. The purpose of these variations is to allow the voluntary use of oil derived from marine micro-algae Schizochytrium sp. (ATCC PTA-9695) as a source of DHA in infant formula products.
The legislation imposes obligations on the Authority to consider applications for the development or variation of food regulatory measures and to undertake public consultation as per Division 1 of Part 3 of the FSANZ Act. The Authority is also required to prepare a draft variation and associated assessment summary, and to call for submissions from the public. There are no documents incorporated by reference in this variation, and a Regulation Impact Statement was not required as the proposed variations are voluntary and expected to have a minor impact.
The statement of compatibility with human rights is exempt from the requirements of the legislation as it is a non-disallowable instrument under section 94 of the FSANZ Act. The variations to Schedule 3 and Schedule 25 include the insertion of references to oil derived from marine micro-algae Schizochytrium sp. (ATCC PTA-9695) and a new section providing a specification for the oil. Additionally, a new reference to the oil is inserted in Schedule 25 with a condition that it may only be added to infant formula products in accordance with Standard 2.9.1.
There are no specific offences, penalties, or consequences for breach outlined in this explanatory statement. However, the FSANZ Act provides a framework for the regulation of food standards and variations, which may include provisions for enforcement and penalties in other sections of the Act. The Authority’s consideration of applications and the preparation of variations are guided by the statutory requirements and procedures outlined in the FSANZ Act.