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 2 of Part 3 of the FSANZ Act specifies that the Authority may prepare a proposal for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering a proposal for the development or variation of food regulatory measures.
FSANZ prepared Proposal P1046 to permit the addition to Food for Special Medical Purposes of the acetate form of the single amino acids listed in section S29—20 of the Code.
Proposal P1046 was declared an Urgent Proposal for the purposes of Division 4 of Part 3 of the FSANZ Act.
The Authority considered the Proposal in accordance with sections 96 and 97 of the FSANZ Act and has approved a draft variation.
2. Purpose
The approved draft variation’s purpose is to amend Schedule 3 to set a specification for L‑arginine acetate and to amend Schedule 29 in order to permit the addition to FSMP of L‑arginine acetate.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
4. Consultation
The Authority considered the Proposal in accordance with the procedure in Division 4 of Part 3 of the FSANZ Act. That consideration included one round of public consultation following an initial consideration and the preparation of a draft variation and associated assessment summary. After that public consultation, the Authority had regard to all submissions received and approved an amended version of the draft variation. The approved draft variation must be reviewed by the Authority within 12 months of its notification in accordance with Subdivision B of Division 4 of Part 3 of the FSANZ Act. Further public consultation is required as a part of that assessment.
A Regulation Impact Statement was not required because the approved draft variation is likely to have only 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 ‘L-arginine acetate’ and to new section S3—38. The effect is that subsection 1.1.1—15(2) of Standard 1.1.1 will require L-arginine acetate, when added to food or sold for use in food, to comply with the specifications listed for L-arginine acetate in the new section.
Item [1.2] inserts new section S3—38 into Schedule 3. New section S3—38 provides the specifications for L-arginine acetate.
Item [2] amends Schedule 29. The item inserts a reference to L-arginine acetate into Column 2 of the table to section S29—20. Paragraph 2.9.5—6(1)(a) of the Code will provide that the effect of this amendment is to permit L-arginine acetate to be added to Food for Special Medical Purposes.
Overview
The Food Standards Australia New Zealand Amendment Regulation 2017 (F2017L01176) was enacted to address a gap in the food regulatory measures concerning the addition of specific amino acids to Food for Special Medical Purposes (FSMP). The Food Standards Australia New Zealand Act 1991 (FSANZ Act) empowers Food Standards Australia New Zealand (the Authority) to develop and vary standards in the Australia New Zealand Food Standards Code. Proposal P1046, declared an Urgent Proposal under the FSANZ Act, sought to amend the Code to permit the addition of the acetate form of certain single amino acids, specifically L-arginine acetate, to FSMP. The approved draft variation aims to set a specification for L-arginine acetate and permit its addition to FSMP, ensuring these substances meet necessary safety and quality standards. The Authority undertook a process of public consultation and review before approving the draft variation, which is subject to further review and potential public consultation within 12 months. This amendment was deemed to have only a minor impact on business and individuals, thereby exempting it from requiring a Regulation Impact Statement.
Scope and Application
The Act applies to Food Standards Australia New Zealand (FSANZ) in its capacity to develop food regulatory measures, including standards, under section 13 of the Food Standards Australia New Zealand Act 1991. This includes the amendment of the Australia New Zealand Food Standards Code to set specifications for L-arginine acetate and to permit its addition to Food for Special Medical Purposes. The Act operates on a national level, as FSANZ is a Commonwealth authority with jurisdiction across Australia. The approved draft variation is subject to a review by FSANZ within 12 months of its notification, and further public consultation is required as part of that review. There are no stated exclusions or exemptions in this specific variation, and no subordinate instruments are referenced to extend or restrict its application. The instrument is exempt from the requirement for a statement of compatibility with human rights as it is a non-disallowable instrument under the FSANZ Act.
Key Provisions
The main provisions of the legislation are outlined in the Explanatory Statement, detailing the Authority's intention to amend the Australia New Zealand Food Standards Code. The legislative instrument, prepared as Proposal P1046, seeks to permit the addition of L-arginine acetate to Food for Special Medical Purposes (FSMP) (Item 1). The proposal includes a new specification for L-arginine acetate in Schedule 3 and an amendment to Schedule 29 to permit its addition to FSMP (Item 2). These amendments are intended to provide clarity and compliance with the standards set out in the Food Standards Australia New Zealand Act 1991 (FSANZ Act). The Authority considered the proposal in accordance with sections 96 and 97 of the FSANZ Act, involving a round of public consultation before approving the draft variation.
The obligations imposed by this Act on the parties or entities it governs include adhering to the new specifications for L-arginine acetate as set out in the amended Schedule 3. Manufacturers and suppliers of FSMP must ensure that any L-arginine acetate added to these products complies with the newly specified standards (Item 1.1). Additionally, the Authority is required to review the approved draft variation within 12 months of its notification and conduct further public consultation as part of this review process (Subdivision B of Division 4 of Part 3 of the FSANZ Act). The Authority’s actions are governed by the FSANZ Act, ensuring that the amendments are made in accordance with the prescribed procedures and considering public submissions.
The legislation does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches of the provisions. However, non-compliance with the standards and specifications set out in the Food Standards Code could potentially lead to enforcement actions by Food Standards Australia New Zealand. Such actions might include recalls, fines, or other regulatory measures as permitted under the FSANZ Act. The precise penalties would depend on the nature and severity of the breach, but they are intended to ensure that food products meet the required safety and quality standards.
This legislative instrument is exempt from the requirement for a statement of compatibility with human rights as it is a non-disallowable instrument under section 94 of the FSANZ Act. The Authority’s decision to approve the draft variation and the subsequent amendments to the Food Standards Code are thus subject to the procedural requirements set out in the FSANZ Act, without the need for additional human rights considerations. The Authority’s consideration of the proposal, including public consultation, ensures that the changes are made in a transparent and accountable manner, consistent with the statutory framework governing food standards in Australia and New Zealand.