Food Standards (Proposal P1064 – Australian only Infant Formula Product Standard) Variation

Administered by Department of Health, Disability and Ageing

Legislation au F2025L00861 Not in force Legislative Instrument

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Explanatory Statement

 

Food Standards Australia New Zealand Act 1991

Food Standards (Proposal P1064 – Australian only Infant Formula Product Standard) 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.

 

FSANZ prepared Proposal P1064 to add or amend Notes in Standards 1.1.1 and 2.9.1 of the Code in order to advise readers that Standard 2.9.1 applies in Australia only.

 

The Authority considered the proposal in accordance with Division 2 of Part 3 and has approved a draft variation - the Food Standards (Proposal P1064 – Australian only Infant Formula Product Standard) 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 will be 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).

 

This instrument is 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 purpose of the approved draft variation is to add or amend Notes in Standard 1.1.1 and 2.9.1 of the Code to reflect that Standard 2.9.1 applies in Australia only and to inform readers of that fact.

 

Standard 2.9.1, the Code’s infant formula products standard, was amended in 2024 as result of Proposal P1028. That Proposal’s regulatory changes were endorsed by the FMM on 25 July 2024 and gazetted on 13 September 2024. On 5 August 2024, the New Zealand Government formally notified the FMM in accordance with paragraph 14 of Annex D of The Agreement between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards System that New Zealand would opt out of the amended infant formula products standard developed under P1028.  As a result, Standard 2.9.1 of the Code now applies in Australia only.

 

4. Documents incorporated by reference

 

The approved draft variation does not incorporate any documents by reference.

 

5. Consultation

 

In accordance with the procedure in Division 2 of Part 3 of the FSANZ Act, the Authority’s consideration of Proposal P1064 included one round of consultation with government agencies in accordance with the FSANZ Act. 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) was not prepared for this proposal. Under changes to impact analysis requirements, the Authority is not required to seek confirmation from the Office of Impact Analysis (OIA) that a RIS is not required. This is because the amendments proposed 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 OIA on similar proposals (for example Proposal P1061 – Code Maintenance Proposal 2023, OIA reference 22-03854).  

 

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

 

Clause 1 of the approved draft variation provides that the name of the variation is the Food Standards (P1064 – Australian only Infant Formula Product Standard) Variation.

 

Clause 2 of the approved draft variation provides that the Code is amended by the Schedule to the variation.

 

Clause 3 of the approved draft variation provides that the variation will commence on the date of gazettal of the instrument.

 

Schedule to the approved draft variation

 

Item [1] of the Schedule would amend subsection 1.1.1—2(2) of the Code.

 

Subsection 1.1.1—2(2) of the Code sets out the structure of the Code and lists each standard. It provides, in effect, a table of contents for the Code. The list of standards in that subsection identifies for readers which standards of the Code apply in Australia only by the use of a Note after the entry for each relevant Chapter or standard.

 

Item [1] amends subsection 1.1.1—2(2) by inserting a Note stating ‘Applies in Australia only’ after the reference in that subsection to Standard 2.9.1. The Note would inform readers of the fact that Standard 2.9.1 of the Code applies in Australia only

 

Item [2] of the Schedule amends Note 1 to subsection 1.1.1—3(1).

 

Section 1.1.1—3 sets out to what food the Code applies. Subsection 1.1.1—3(1) provides that, unless stated otherwise, the Code applies to food that is sold, processed or handled for sale or imported into Australia or New Zealand. Note 1 to that subsection lists those standards or provisions in the Code which the New Zealand Government has not incorporated or adopted under the Food Act 2014 (NZ).

 

The approved draft variation amends the above-mentioned list in Note 1 of subsection 1.1.1—3(1) by replacing the existing paragraph (vii) – which refers to ‘Chapter 3 (food safety standards) and Chapter 4 (primary production and processing standards)’ - with three new paragraphs as follows:

 

 (vii) Standard 2.9.1 (infant formula products);

 (viii) Chapter 3 (food safety standards);

 (vix) Chapter 4 (primary production and processing standards).

 

The effect of this amendment is to add Standard 2.9.1 to the list in Note 1 of Code provisions that have not been incorporated or adopted under the Food Act 2014 (NZ). It also separates the references to Chapter 3 (food safety standards) and Chapter 4 (primary production and processing standards), currently combined in one paragraph (vii), into their own paragraphs: (viii) and (vix).

 

The amendment will inform readers of the fact that Standard 2.9.1 of the Code applies in Australia only.

 

Item [3] of the Schedule repeals and replaces Note 2 to the title of Standard 2.9.1.

 

The Code identifies standards that do not apply in New Zealand by use of a note under the title of the relevant standard and that states the standard applies in Australia only.

 

At present, the following note is included under the title of Standard 2.9.1:

 

Note 2  The provisions of the Code that apply in New Zealand are incorporated in, or adopted under, the Food Act 2014 (NZ). See also section 1.1.1—3.

 

This note is now incorrect as Standard 2.9.1 of the Code (as amended by Proposal P1028) has not been incorporated in or adopted under the New Zealand Food Act and does not apply in New Zealand

 

Item [3] amends the text of Note 2 to state as follows:

Note 2     This Standard applies in Australia only. New Zealand has under Annex D of the Agreement between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards System opted out of this Standard. See also section 1.1.1—3.

The amended Note would inform readers of the fact that Standard 2.9.1 of the Code applies in Australia only. The above is the same approach as taken for other standards of the Code that do not apply in New Zealand, such as Standard 1.4.2 – Agvet chemicals and Standard 1.6.2 – Processing requirements for meat.

Overview

The Food Standards Australia New Zealand Act 1991 (FSANZ Act) was enacted to establish a framework for the development and enforcement of food standards across Australia and New Zealand, ensuring consumer protection and harmonising food regulation between the two countries. The Act addresses the problem of fragmented food regulation by establishing Food Standards Australia New Zealand (FSANZ) as the body responsible for developing and maintaining food standards. The FSANZ Act was enacted by the Parliament of Australia and aims to provide a uniform and consistent approach to food regulation, facilitating trade and ensuring public health protection. Recently, the FSANZ Act has been used to introduce variations in the Australia New Zealand Food Standards Code, such as Proposal P1064, which modifies certain standards to clarify their application in Australia only, following New Zealand's decision to opt out of certain standards. This legislative instrument is subject to disallowance or sunsetting provisions as outlined in the Legislation Act 2003.

Scope and Application

The Food Standards (Proposal P1064 – Australian only Infant Formula Product Standard) Variation, established under the Food Standards Australia New Zealand Act 1991, serves to amend the Australia New Zealand Food Standards Code to clarify that the infant formula products standard, Standard 2.9.1, applies exclusively in Australia. The Authority, Food Standards Australia New Zealand, prepared this proposal and followed the procedure outlined in Division 2 of Part 3 of the FSANZ Act, including consultation with government agencies, before approving the draft variation. This legislative instrument is subject to disallowance or sunsetting provisions as per the Legislation Act 2003, although it is exempt from sunsetting because it gives effect to an international obligation of Australia. The approved draft variation aims to update the Code to reflect that Standard 2.9.1 does not apply in New Zealand following their formal opt-out notification. This amendment is intended to ensure that readers are clearly informed about the jurisdictional applicability of the Code's standards. The variation will come into effect on the date of its gazettal and registration, at which point it will become part of the Commonwealth, State, and Territory food laws in Australia.

Key Provisions

The Food Standards (Proposal P1064 – Australian only Infant Formula Product Standard) Variation, as detailed in the explanatory statement, amends the Australia New Zealand Food Standards Code to clarify the application of certain standards in Australia and New Zealand. Section 1 of the variation specifies the name of the instrument, while section 2 directs that the Code is amended as per the Schedule to the variation (Section 2). This amendment is effective from the date of gazettal of the instrument (Section 3). The Schedule amends subsection 1.1.1—2(2) of the Code by adding a note stating that Standard 2.9.1 applies in Australia only (Item [1]). It also amends Note 1 to subsection 1.1.1—3(1) to include a new paragraph listing Standard 2.9.1 separately from food safety and primary production and processing standards (Item [2]). Finally, Item [3] amends Note 2 to the title of Standard 2.9.1 to clarify that the standard applies in Australia only and that New Zealand has opted out of this standard. The Food Standards Australia New Zealand Act 1991 imposes several obligations on the Authority, including the development and variation of food standards, as specified in Section 13. The Authority must follow the procedure outlined in Division 2 of Part 3 of the FSANZ Act when considering proposals for variations in food regulatory measures. Once a proposal is approved and endorsed by the Food Ministers’ Meeting, the Authority is required to publish a notice about the approved draft variation, as mandated by Section 92 of the FSANZ Act. The Authority also engages in consultation with government agencies, as stipulated by the FSANZ Act, to ensure that the proposal is thoroughly considered before it is approved. The Act also outlines several potential consequences for non-compliance with the food standards established under it. While the explanatory statement does not specify particular offences or penalties, breaches of food standards generally result in civil or criminal penalties. For example, under Australian food laws, non-compliance can lead to fines, product recalls, and, in severe cases, imprisonment. The maximum penalties for breaches depend on the specific offence and jurisdiction, but they can be substantial, reflecting the importance of food safety and public health. The approved draft variation is a legislative instrument subject to the disallowance or sunsetting provisions of the Legislation Act 2003. However, it is exempt from these provisions because it facilitates the operation of an intergovernmental scheme involving the Commonwealth and one or more states and gives effect to Australia’s international obligations. This exemption is in line with the provisions of the Legislation Act 2003 and the Legislation (Exemptions and other Matters) Regulation 2015. The Authority’s consideration of Proposal P1064 included a round of consultation with government agencies, and the Authority’s response to the issues raised during consultation is available in an approval report on its website. Given the minor regulatory impact of the amendments, a regulation impact statement was not prepared for this proposal.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.