EXPLANATORY STATEMENT
Food Standards Australia New Zealand Act 1991
Food Standards Australia New Zealand (Declaration of a Food) Declaration 2025
Purpose and operation
The purpose of this instrument is to declare that that cell biomasses and cell lines are considered food under Commonwealth law. This is to facilitate effective management of risks associated with sourcing, production, and consumption of cell-cultured food. This ensures safety and suitability of cell-cultured food, and provides legislative certainty for industry, regulators, and consumers.
Commonwealth, New Zealand, and Australian State and Territory legislation sets out the requirements for food sold in Australia and New Zealand. Food Standards Australia New Zealand (FSANZ) develop food standards which are incorporated into and become part of Commonwealth, State and Territory and New Zealand food laws.
Recently, new food standards were introduced into the Australia New Zealand Food Standards Code (Food Standard 3.4.1 of the Australia New Zealand Food Standards Code) that specify the conditions under which cell-cultured foods—including those used as ingredients—may be sold. These standards also outline requirements for the safety, use, and labelling of such foods.
To support consistent enforcement across Australia, this legislative instrument—Food Standards Australia New Zealand (Declaration of a Food) Declaration 2025—formally declares cell lines and cell biomasses (as defined in Food Standard 3.4.1 of the Australia New Zealand Food Standards Code on the day the instrument commences) to be food for the purposes of the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Other State and Territory legislation will then incorporate by reference this declaration into their food laws.
Section 5 of the FSANZ Act defines the term "food." Additionally, section 6 allows the Minister to declare substances or things as food for the purposes of the FSANZ Act. State and Territory food laws recognise such declarations under section 6 as binding for the purposes of their respective food laws.
Authority
Subsection 6(1) of the FSANZ Act provides that after consulting FSANZ (referred to in the FSANZ Act as the Authority), the Minister may, by legislative instrument, declare that a substance or thing is food for the purposes of the FSANZ Act.
Subsection 6(2) of the FSANZ Act provides that the Minister must also ensure that a copy of the declaration is published in the New Zealand Gazette.
Subsection 6(3) of the FSANZ Act provides that a declaration under subsection 6(1) takes effect on the day specified in the declaration. That day must not be a day before the declaration is published.
Incorporation by reference
This instrument uses certain defined terms from the Australia New Zealand Food Standards Code – Standard 3.4.1 – Food safety requirements for processing of cell-cultured food (Food Standard 3.4.1). These terms are adopted as they appear in the version of Food Standard 3.4.1 that is in force on the date this instrument commences. Food Standard 3.4.1 can be accessed on the Federal Register of Legislation website (www.legislation.gov.au).
Commencement
This instrument commences on the day after the later of the registration on the Federal Register of Legislation or the day a copy of the instrument is published in the New Zealand Gazette (available here: https://gazette.govt.nz/).
Consultation
The Department of Health, Ageing and Disability undertook consultation with FSANZ, jurisdictional officers from Australian states and territories and the New Zealand Government in the development of the instrument to ensure that the instrument would address the issues raised regarding enforcement during the development of the Food Standard.
As required in subsection 6(1) of the FSANZ Act, the Minister also consulted FSANZ before making the instrument.
General
This instrument is a legislative instrument for the purposes of the Legislation Act 2003.
This 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):
- facilitates the establishment or operation of an intergovernmental scheme involving the Commonwealth and one or more States; and
- authorises the instrument to be made for the purposes of the scheme.
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.
Details of this instrument are set out in Attachment A.
ATTACHMENT A
Details of the Food Standards Australia New Zealand (Declaration of a Food) Declaration 2025
Section 1 – Name
Section 1 provides that the name of the instrument is the Food Standards Australia New Zealand (Declaration of a Food) Declaration 2025.
Section 2 – Commencement
Section 2 provides that the instrument takes effect on the day after the later of the following:
- the day the instrument is registered on the Federal Register of Legislation;
- the day a copy of the instrument is published in the New Zealand Gazette.
Section 3 – Authority
Section 3 provides that the instrument is made under subsection 6(1) of the Food Standards Australia New Zealand Act 1991.
Section 4 – Definitions
This section provides the definitions of terms used in the declaration.
It provides as follows:
- The term ‘Act’ means the Food Standards Australia New Zealand Act 1991.
- A reference in the instrument to ‘Standard 3.4.1’ is to the Australia New Zealand Food Standards Code – Standard 3.4.1 – Food safety requirements for processing of cell-cultured food as in force on the day this instrument commences.
- A reference in the instrument to a ‘cell biomass’ has the same meaning as in Standard 3.4.1. Standard 3.4.1 defines a ‘cell biomass’ to mean a mass of cells extracted from a bioreactor and that is intended for use in the production of a food.
- A reference in the instrument to a ‘cell line’ has the same meaning as in Standard 3.4.1. Standard 3.4.1 defines a ‘cell line’ to mean a collection of cells that: (a) are derived from a single source that was prepared under specific culture conditions; and (b) have a uniform composition; and (c) are intended for use in the production of a cell biomass.
Section 5 – Declaration of cell lines as a food
Section 5 provides that cell lines (as defined in Food Standard 3.4.1) are declared a food.
Section 6 – Declaration of cell biomass as a food
Section 6 declares a cell biomass (as defined in the Australia New Zealand Food Standards Code) as food.