Explanatory Statement
Food Standards Australia New Zealand Act 1991
Food Standards (Proposal P1065 – Code Revision – 2025 amendments (Compositional requirements for Special Medical Purpose Product for infants and other miscellaneous amendments)) Variation
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.
The Authority prepared Proposal P1065 to correct the compositional fat requirements for Special Medical Purpose Product for infants and to make other minor amendments to the Code. The Authority considered the Proposal in accordance with Division 2 of Part 3 of the FSANZ Act and has approved a draft variation – the Food Standards (Proposal P1065 – Code Revision – 2025 amendments (Compositional requirements for Special Medical Purpose Product for infants and other miscellaneous amendments)) Variation (the approved draft variation).
Following consideration by the Food Ministers’ Meeting (FMM), section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the approved draft variation.
2. Variation is a legislative instrument
The approved draft variation is a legislative instrument for the purposes of the Legislation Act 2003 (see section 94 of the FSANZ Act) and is publicly available on the Federal Register of Legislation (www.legislation.gov.au).
The instrument is not subject to the disallowance or sunsetting provisions of the Legislation Act 2003. Subsections 44(1) and 54(1) of that Act provide that a legislative instrument is not disallowable or subject to sunsetting if the enabling legislation for the instrument (in this case, the FSANZ Act): (a) facilitates the establishment or operation of an intergovernmental scheme involving the Commonwealth and one or more States; and (b) authorises the instrument to be made for the purposes of the scheme. Regulation 11 of the Legislation (Exemptions and other Matters) Regulation 2015 also exempts from sunsetting legislative instruments a primary purpose of which is to give effect to an international obligation of Australia.
The FSANZ Act gives effect to an intergovernmental agreement (the Food Regulation Agreement) and facilitates the establishment or operation of an intergovernmental scheme (national uniform food regulation). That Act also gives effect to Australia’s obligations under an international agreement between Australia and New Zealand. For these purposes, the Act establishes the Authority to develop food standards for consideration and endorsement by the Food Ministers Meeting (FMM). The FMM is established under the Food Regulation Agreement and the international agreement between Australia and New Zealand, and consists of New Zealand, Commonwealth and State/Territory members. If endorsed by the FMM, the food standards on gazettal and registration are incorporated into and become part of Commonwealth, State and Territory and New Zealand food laws. These standards or instruments are then administered, applied and enforced by these jurisdictions’ regulators as part of those food laws.
3. Purpose
The Authority approved the draft variation to amend the Code to:
- include compositional fat requirements for Special Medical Purpose Product for infants that were considered and approved in Proposal P1028 but which were inadvertently omitted from the Code amendments made by that Proposal; and
- correct other omissions, inconsistencies, formatting issues and typographical errors in the Code; and
- update references in the Code.
4. Documents incorporated by reference
Section 14 of the Legislation Act 2003 provides that a legislative instrument (for example, the draft variation) may (among other things):
incorporate any other matter contained in any other instrument or document in writing, which in force or exists at the time the legislative instrument commences, or a time before its commencement irrespective of whether the document still exists at the time the legislative instrument commences.
The following Code provisions incorporate by reference written documents in accordance with the above section. The draft variation would amend these provisions to update references to an incorporated document. This reference by incorporation is consistent with section 14 of the Legislation Act 2003 and the current practice in the Code.
Standard 1.1.2
The definition of ‘permitted flavouring substance’ in subsection 1.1.2—2(3) of the Code incorporates certain publications by reference. These include Edition 30 (1960 to 2022) of the Generally Recognised as Safe (GRAS) lists of flavouring substances published by the Flavour and Extract Manufacturers’ Association of the United States (FEMA). This reference is now outdated as FEMA has published Edition 31 (1960 to 2024) of its GRAS lists of flavouring substances. The approved draft variation amends the definition of ‘permitted flavouring substance’ to replace the current reference to the 30th Edition with a reference to the 31st Edition.
Schedule 3
Section 1.1.1—15 of the Code requires certain substances to comply with any relevant identity and purity specifications listed in Schedule 3 of the Code when added to food in accordance with the Code or sold for use in food.
Schedule 3 of the Code incorporates certain publications by reference to set specifications for various substances in the circumstances specified in that Schedule. The publications listed include the following:
- the Combined Compendium of Food Additive Specifications published by the Food and Agriculture Organisation of the United Nations/World Health Organisation Expert Committee on Food Additives (JECFA) in the Monographs listed in Schedule 3;
- the 13th edition (2022) of the Food chemicals codex published by the United States Pharmacopeial Convention; and
- the edition of the International Oenological Codex published by the Organisation Internationale de la Vigne et du Vin (OIV) in 2022.
The approved draft variation amends Schedule 3 to update these references to refer to the following.
- JECFA has added new Monographs 27 (2022), 30 (2022), 31 (2023), 32 (2024) and 34 (2025) to its Compendium of Food Additive Specifications. Copies are freely and publicly available online at https://www.fao.org/food/food-safety-quality/scientific-advice/jecfa/jecfa-additives/en/
- The OIV has published a new edition (2025) of the International Oenological Codex. A copy is freely and publicly available online at https://www.oiv.int/standards/international-oenological-codex.
- The United States Pharmacopeial Convention has published a new 2024 (14th edition) of the Food chemicals codex (FCC). A copy is available online at https://www.foodchemicalscodex.org/
The FCC is not available for free. However, it is anticipated that those persons most affected by its adoption in the Code (food manufacturers), would be in possession of the document in order to manufacture food products. As important international benchmark for the safety and quality of food ingredients, it would be infeasible from a regulatory perspective to not adopt such benchmarks on the basis that the publications are not available for free.
However, by prior written arrangement with the Authority, members of the public may arrange to view the FCC without charge at the Authority’s Wellington and Canberra Offices.
The National Library’s Trove online system (www.trove.nla.gov.au) allows users to identify libraries in Australia that are open to the public where editions (in most cases, earlier editions) of the FCC may be viewed. Members of the public may also approach any library that participates in inter-library loans with those university libraries to request an inter‑library loan, or to obtain a photocopy of a particular part or monograph for personal study or research (but not for commercial purposes). Fees apply in relation to the making of such a request. Enquiries can be made through local libraries, State libraries and the National Library.
5. Consultation
In accordance with the procedure in Division 2 of Part 3 of the FSANZ Act, the Authority’s consideration of Proposal P1065 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 6 November 2025 for a 4-week consultation period. Further details of the consultation process, the issues raised during consultation and by whom, and the Authority’s response to these issues are available in an approval report published on the Authority’s website at www.foodstandards.gov.au.
A regulation impact statement (RIS) has not been prepared for this proposal. This is because the amendments in the approved draft variation are considered unlikely to have more than a minor regulatory impact. This is in line with previous advice from the Office of Impact Analysis (OIA) on similar proposals (for example Proposal P1061 – Code Maintenance Proposal 2023, OIA reference 22-03854). Under changes to impact analysis requirements, the Authority was not required to seek confirmation from the OIA that a RIS is not required.
6. 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 44 of the Legislation Act 2003.
7. Variation
References to ‘the variation’ in this section are taken to be references to the approved draft variation.
Clause 1 of the variation provides that the name of the variation is the Food Standards (Proposal P1065 – Code Revision – 2025 Amendments (Compositional requirements for Special Medical Purpose Product for infants and other miscellaneous amendments)) Variation.
Clause 2 of the variation provides that the Code is amended by the Schedule to the variation.
Clause 3 of the variation provides that the variation commences on the date of gazettal of the instrument.
Clause 4 provides a transitional arrangement for the amendment made by Item [11] of the Schedule.
Subclause 4(1) provides that the stock-in-trade exemption provided by section 1.1.1—9 of Standard 1.1.1 does not apply to the amendment made by Item [11] of the Schedule.
Instead, subclauses 4(2) and (3) provide a transitional arrangement where, during a transitional period commencing on the date of gazettal of the variation, a food product may be sold if the product complies with one of the following:
- the Code as in force at the time of sale, including as amended by each of the following:
- Item [11] of the Schedule; and
- the Food Standards (Proposal P1028 – Infant Formula) Variation; and
- the Food Standards (Proposal P1028 – Infant Formula – Consequential Amendments) Variation; or
- the Code as in force at the time of sale, but without the amendments made by the each of the above.
Subclause 4(3) also provides that this transition period ends on 13 September 2029. This is the end date for the transitional period for the amendments made by Food Standards (Proposal P1028 – Infant Formula) Variation and which should have included the amendment now being made by Item [11] of the Schedule.
8. Schedule to the variation
As explained above, each Item of the Schedule amends the Code.
8.1 Reflecting the amendments made to the compositional fat requirements for Special Medical Purpose Product for infants
Item [11] of the Schedule will amend subsection 2.9.1—34(2) by repealing the subsection and replacing it with a new subsection.
Current subsection 2.9.1—34(2) provides that a Special Medical Purpose Product for infants may only contain medium chain triglycerides that are either: a natural constituent of a milk-based ingredient of that product; or for a fat soluble vitamin that is specified in the table to section S29—5, a substance that was used as a processing aid in the preparation of that permitted fat soluble vitamin for use in the Special Medical Purpose Product for infants.
The phrase ‘used as a processing aid’ in relation to a food is defined in section 1.1.2—13 of the Code.
New subsection 2.9.1—34(2) will provide that a Special Medical Purpose Product for infants may only contain medium chain triglycerides that: (a) contain predominantly the saturated fatty acids designated by 8:0 and 10:0; and (b) are one of the following:
(i) a natural constituent of a milk-based ingredient of that product; or
(ii) for a fat soluble vitamin that is specified in the table to section S29—5—a substance that was used as a processing aid in the preparation of that permitted fat soluble vitamin for use in the product.
The new subsection’s compositional fat requirements for Special Medical Purpose Product for infants are identical to those currently set by paragraph 2.9.1—7(2)(a) of the Code for infant formula.
The requirement in the new subsection that permitted medium chain triglycerides must contain predominantly the saturated fatty acids designated by 8 to 0 and 10 to 0 should have been included by and with the amendments made by the Food Standards (Proposal P1028 – Infant Formula) Variation.
The amendment made by Item [11] of the Schedule will correct that drafting error.
8.2 Correcting typographical errors, omissions, inconsistencies and formatting
Items [2] – [10], and [12], [16] – [48] of the draft variation include amendments to correct typographical errors, omissions, and formatting issues; and to improve consistency across the Code.
8.3 Updating references
Items [1], and [13] – [15] of the draft variation include amendments to update references in the Code.