Australia New Zealand Food Standards Code – Standard 1.5.4 – Cell-cultured foods

This instrument inserts Standard 1.5.4 into the Australia New Zealand Food Standards Code and sets an initial regulatory framework for what the Code calls “cell‑cultured food”. It does three mechanical things.

First, it defines the term cell‑cultured food, as “a food obtained by culturing cells isolated from any of the following sources: livestock; poultry; game; seafood (including fish); an egg or an embryo of any of the former” (s 1.5.4,2). That definition is the gate for everything that follows.

Second, it makes permissibility conditional. A cell‑cultured food may be sold only if it is listed in Schedule 25A and any corresponding conditions in that Schedule are complied with (s 1.5.4,3(a)-(b)). The Standard therefore separates approval/authorisation (the Schedule) from the general labelling and use rules set out in the body of the Standard.

Third, it imposes a three‑part labelling and use regime plus a use prohibition. The Standard:

• Prohibits adding a cell‑cultured food to any food standardised by Part 2.9 of the Code (s 1.5.4,4). Part 2.9 is the set of “special purpose foods”; the Standard therefore excludes cell‑cultured inputs from those defined special‑purpose products.
• Requires specific ingredient labelling: where a food for sale contains a cell‑cultured food as an ingredient, the ingredient’s name must be used in conjunction with one of two prescribed statements, “cell‑cultured” or “cell‑cultivated” (s 1.5.4,5(1)-(2)). The labelling provisions referenced are those in Standard 1.2.1, and they apply to packaged and unpackaged food.
• Sets additional name‑of‑food rules for retail packaged food that is represented as from the source animal: if a packaged food for retail sale contains a cell‑cultured ingredient and is represented in words or images as being from the animal from which the cell was sourced, the name of the food must use the same “cell‑cultured” or “cell‑cultivated” statement in conjunction with the food name (s 1.5.4,6(1)(a)-(d); 6(3)). For non‑retail sale (Division 3 or 4 of Standard 1.2.1), a packaged cell‑cultured food must use the same prescribed statements in conjunction with its name (s 1.5.4,7).

The Standard commences on the date of gazettal (note to s 1.5.4,1; Gazette date shown as 18 June 2025). The Board of FSANZ made the Standard and a delegate signed the notice (heading material dated 10 June 2025). The Standard is explicitly a standard under the Food Standards Australia New Zealand Act 1991 (Cth) and forms part of the Australia New Zealand Food Standards Code (Note 1); the Code’s provisions apply in New Zealand through incorporation/adoption under New Zealand’s Food Act 2014 (Note 2). Mechanically, the Standard creates eligibility rules (Schedule 25A), use prohibitions (Part 2.9 foods), and mandatory wording for labelling in limited and specified circumstances.

The Standard rests on a small set of explicit legal concepts and a few cross‑references to other Code provisions.

Definitional gate

• Cell‑cultured food (s 1.5.4,2). The definition focuses on the provenance of the cells that are cultured: cells isolated from livestock, poultry, game, seafood (including fish), an egg or an embryo of any of those. The definition determines the universe of material the Standard regulates.

Permissibility and authorisation

• Schedule 25A as the permissibility list (s 1.5.4,3). The Standard does not itself list permissible cell‑cultured foods; it requires that any cell‑cultured food must appear in Schedule 25A and that any corresponding Schedule conditions must be complied with. That design separates product identification and conditions (Schedule) from general rules.

Restricted uses

• Prohibition with respect to Part 2.9 (s 1.5.4,4). Foods standardised under Part 2.9,the Code’s “special purpose foods”,cannot include a cell‑cultured food. This is a categorical exclusion rather than a label/consumer information rule.

Labelling architecture

• Ingredient labelling (s 1.5.4,5). If a food for sale contains a cell‑cultured ingredient, the ingredient must be accompanied by one of two precise descriptors, “cell‑cultured” or “cell‑cultivated”, in accordance with labelling provisions of Standard 1.2.1. The Standard applies to packaged and unpackaged foods (note to s 1.5.4,5).
• Name‑of‑food labelling for retail packaged items represented as from the animal (s 1.5.4,6). If a packaged retail food that contains a cell‑cultured ingredient is represented as being from the source animal, then the same “cell‑cultured” or “cell‑cultivated” statement used in the ingredient listing must appear in the name of the food itself (s 1.5.4,6(3)). The provision exempts ingredient list references to the animal (s 1.5.4,6(2)).
• Name‑of‑food labelling for non‑retail sale (s 1.5.4,7). For non‑retail sales where Division 3 or 4 of Standard 1.2.1 applies (for example, sales to caterers; the Standard gives an example), a packaged cell‑cultured food must include one of the two prescribed statements in conjunction with the food name.

Integration with labelling standards

• The Standard repeatedly cross‑references existing labelling rules in Standard 1.2.1 and the naming rules in Standard 1.2.2 (see notes to s 1.5.4,5, s 1.5.4,6, and s 1.5.4,7). The Standard therefore modifies labelling outcomes by specifying additional, mandatory text while relying on the location, format and broader labelling obligations in those other Standards.

The Standard creates obligations and constraints that fall on a limited set of market participants and public actors. The primary affected parties are producers of cell‑cultured foods, businesses that incorporate cell‑cultured ingredients, labelling and marketing teams, and regulatory decision‑makers.

Producers and potential entrants

• Any person or entity that produces cell‑cultured foods must secure a position in Schedule 25A and comply with any conditions listed there in order to lawfully sell their product (s 1.5.4,3). That creates a procedural gate: without an entry in Schedule 25A, a cell‑cultured product cannot be sold. The Standard therefore affects R&D and commercialisation decisions by producers, whether start‑ups, established food processors, or multinational companies.

Food manufacturers and formulators

• Manufacturers that wish to use cell‑cultured materials as ingredients must ensure the specific cell‑cultured food is in Schedule 25A and satisfy any Schedule conditions (s 1.5.4,3). They must also adjust ingredient declarations to include the prescribed statement “cell‑cultured” or “cell‑cultivated” next to the ingredient name (s 1.5.4,5). That affects label copy, formulation information, batch records and supply‑chain documentation.

Retailers and food‑service suppliers

• Packaged foods for retail sale that contain a cell‑cultured ingredient and are represented as being from the source animal must include the prescribed descriptor in the product’s name (s 1.5.4,6(1)(a)-(d), 6(3)). Retail marketing, packaging design, and point‑of‑sale materials therefore must reflect the specified language where the representation trigger is met.
• Businesses selling to caterers or operating in non‑retail channels must follow s 1.5.4,7 where Division 3 or 4 of Standard 1.2.1 applies. The Standard’s example explicitly addresses packaged food sold to a caterer, which must include the “cell‑cultured” or “cell‑cultivated” statement in the name.

Label designers, legal and compliance teams

• The Standard prescribes only two permitted descriptors: “cell‑cultured” and “cell‑cultivated” (s 1.5.4,5(2), 1.5.4,7(2)). Those drafting labels must restrict themselves to these two options and place the statement in the ingredient list and, in some cases, the product name, consistent with Standard 1.2.1 and Standard 1.2.2 (notes to s 1.5.4,5, 6, 7).

Regulators and food standard administrators

The Standard imposes a set of specific duties, and it creates corresponding entitlements for regulators to permit or refuse market access via Schedule 25A.

Core duties imposed on suppliers and food businesses

• Duty to be listed and comply with conditions: A food for sale that is, or has as an ingredient, a cell‑cultured food may only be sold if the cell‑cultured food is listed in Schedule 25A and the corresponding conditions in that Schedule are complied with (s 1.5.4,3(a)-(b)). Practically, the duty includes obtaining whatever authorisation process is implemented to achieve listing and complying with the Schedule’s conditions, which may include composition, safety, labelling, traceability or other requirements (the text of Schedule 25A is not included here).
• Duty not to use in Part 2.9 foods: No cell‑cultured food may be added to any food standardised by Part 2.9 (s 1.5.4,4). That is an exclusionary duty: actors must not include a cell‑cultured ingredient in foods that are defined by the Code under Part 2.9.
• Labelling duties for ingredient declarations: Where a food for sale contains a cell‑cultured ingredient, labelling must use the statement “cell‑cultured” or “cell‑cultivated” in conjunction with the ingredient name under the labelling provisions in Standard 1.2.1 (s 1.5.4,5(1)-(2); note).
• Labelling duties for the name of the food in retail packaged cases: For retail packaged goods that are represented as being from the source animal and that contain a cell‑cultured ingredient, the name of the food must include the same “cell‑cultured” or “cell‑cultivated” statement (s 1.5.4,6(1)(a)-(d), 6(3)). The provision does not require such a name statement where words or images do not represent the product as being from the animal (s 1.5.4,6, example).
• Labelling duties for non‑retail sales: For non‑retail sales where Division 3 or 4 of Standard 1.2.1 applies, the name of a packaged cell‑cultured food must include “cell‑cultured” or “cell‑cultivated” in conjunction with the food name (s 1.5.4,7(1)-(2)).

Prescribed language and labelling scope

• Duty to use only the prescribed descriptors: The Standard confines the disclosure language to two options, “cell‑cultured” or “cell‑cultivated”, for both ingredient statements and name‑of‑food statements where required (s 1.5.4,5(2); s 1.5.4,7(2); s 1.5.4,6(3)). The labelling provisions in Standard 1.2.1 govern how those words are presented on packaged and unpackaged foods.

Regulatory entitlements and processes

The text of Standard 1.5.4 itself does not set out penalties, enforcement mechanisms, or administrative sanctions. The instrument is presented as a Standard under the Food Standards Australia New Zealand Act 1991 (Cth) and as part of the Australia New Zealand Food Standards Code (Note 1). It also notes that Code provisions that apply in New Zealand are incorporated in, or adopted under, the Food Act 2014 (NZ) (Note 2). Those references establish the legal context in which enforcement will occur but the Standard’s text does not include express penalty clauses.

What the Standard does tell us about enforcement architecture by implication and cross‑reference

• The Standard is part of the Code: Because this instrument is a standard under the FSANZ Act and forms part of the Australia New Zealand Food Standards Code (Note 1), enforcement and penalties relevant to breaches of Code requirements will generally be applied under the enforcement frameworks that give effect to the Code in jurisdictions. The text points readers to existing legislative mechanisms (FSANZ Act; Food Act 2014 (NZ)) without specifying sanctions or procedures.
• Application across jurisdictions: The Note that Code provisions apply in New Zealand through the Food Act 2014 (NZ) (Note 2) implies that enforcement in New Zealand will be under the regime created by the Food Act 2014, while in Australia enforcement and any penalties will operate through the respective state and territory laws that apply the Code, and through Commonwealth instruments as relevant. The Standard itself leaves the specifics of enforcement to those instruments and administrative authorities.

Consequences for practitioners

• Absence of penalties in the Standard means that compliance and enforcement risk must be analysed against the enforcement provisions of the Code as implemented in each jurisdiction, and against any conditions in Schedule 25A that might impose requirements enforceable under other parts of the Code. The Standard’s cross‑references to Standard 1.2.1 and 1.2.2 mean contraventions of the labelling duties will also intersect with the enforcement provisions that govern those Standards.
• Practical enforcement vectors: In practice, regulators that administer the Code will be able to treat non‑compliant labelling or unauthorised sale of a cell‑cultured food (i.e. sale where the product is not listed in Schedule 25A) as a breach of the Code or the enabling food law of a jurisdiction. The Standard, however, does not itself define the enforcement steps, evidentiary requirements, or sanctioning processes.

The Standard is cross‑linked to the broader Code and to the statutes and Standards that implement and support the Code. The text both depends on and modifies the operation of other Code provisions.

Relationship with the Australia New Zealand Food Standards Code

• Part of the Code: The Standard is expressly a Standard under the Food Standards Australia New Zealand Act 1991 (Cth) and forms part of the Australia New Zealand Food Standards Code (Note 1). As such, it sits alongside and interacts with other Standards in the Code, primarily the labelling Standards (1.2.1 and 1.2.2) and Part 2.9 (special purpose foods), which it explicitly references and constrains.

Cross‑references to labelling and naming Standards

• Standard 1.2.1 (labelling) and Standard 1.2.2 (naming): The instrument repeatedly instructs that the labelling provisions to be used are those in Standard 1.2.1 (see notes to s 1.5.4,5, s 1.5.4,6, s 1.5.4,7). It also explicitly states that where a packaged retail food containing a cell‑cultured ingredient is not represented as being from the animal, Standard 1.2.2 applies (s 1.5.4,6 example). The Standard therefore modifies outcomes created by 1.2.1 and 1.2.2 by adding mandatory descriptors for particular circumstances while leaving placement, format, legibility and other labelling conventions to those existing Standards.

Interaction with Part 2.9

• Exclusionary rule: Section 1.5.4,4 creates a direct interaction with Part 2.9 by prohibiting the addition of any cell‑cultured food to foods standardised by Part 2.9. Part 2.9 defines and regulates “special purpose foods”; the Standard therefore carves out that part of the Code as a protected space where cell‑cultured inputs are not permitted. This is a direct constraint on product formulation where Part 2.9 applies.

Relationship with Schedule 25A

• Product‑level authorisation: The Standard hands off permissibility to Schedule 25A (s 1.5.4,3). The interaction is hierarchical: the substantive rules in the body of the Standard apply only if the product is listed in Schedule 25A and any corresponding conditions are complied with. The Schedule will therefore be the place where specific technical or safety conditions are imposed. The Standard leaves the content of those conditions to the Schedule.

Interaction with national laws and New Zealand law

• FSANZ Act context and New Zealand incorporation: Note 1 states the Standard is made under the Food Standards Australia New Zealand Act 1991 (Cth) and that it forms part of the Code; Note 2 states that provisions of the Code that apply in New Zealand are incorporated or adopted under the Food Act 2014 (NZ). The Standard therefore operates through the framework by which the Code is given legal force: in Australia, via Commonwealth, state and territory arrangements that apply the Code; in New Zealand, via the Food Act’s incorporation/adoption mechanism. Enforcement, penalties and operational implementation will follow those instruments.

The text supplied sets out the origin and commencement information for this Standard but does not record any prior amendments or a legislative history prior to the decision recorded.

Key dates and formalities recorded in the instrument

• Date of the Board notice and signing: The Board’s notice is dated 10 June 2025, signed by the delegate of the Board, Matthew O’Mullane, General Manager, Food Safety (heading material).
• Gazettal and commencement: The instrument states it will be published in the Commonwealth of Australia Gazette No. FSC 179 on 18 June 2025, and that the date of publication in the Gazette is the gazettal date and the commencement date (note to s 1.5.4,1; the heading material states the gazettal date as 18 June 2025). The Standard therefore commences on the date of gazettal.
• Legal basis: The notice sets the legal basis for making the Standard under section 92 of the Food Standards Australia New Zealand Act 1991 (heading material). The Standard itself states that it is a Standard under that Act (Note 1).

Absence of earlier versions or amendments in the text

• The instrument does not record prior versions, transitional provisions, or amendment history. There are no marginal notes showing insertions into an existing Standard and no explicit “amends” clause. The text should therefore be treated, based on the instrument itself, as a newly made Standard taking effect on the published gazettal date.

Schedule 25A and future amendment pathway

• The Standard delegates product permissions and “corresponding conditions” to Schedule 25A (s 1.5.4,3). The legal mechanism for changing which products are permitted, and what conditions attach, will be through amendments to Schedule 25A and possibly through amendments to this Standard via the FSANZ rule‑making and gazettal process under the FSANZ Act. The instrument does not set out any transition periods, grandfathering or phased implementation steps.

Implication for market participants

• Because the Standard is newly made and depends on Schedule 25A for permitted products and conditions, market participants face a two‑step timeline: the Standard comes into force on gazettal, but the operational details that enable particular products to enter the market will be established by Schedule 25A entries and any associated administrative processes. The Standard’s text provides the legal framework but not the product list or conditions; those will drive subsequent compliance obligations and potential amendments.

The text supplied contains no litigation history. There are no cases mentioned, no judicial decisions referenced, and no indication in the instrument of pending legal challenges. The instrument is a standard made by the Board under the Food Standards Australia New Zealand Act 1991 (Cth) and dated and gazetted on the dates recorded (heading material and note to s 1.5.4,1). It contains no statutory notes, transitional enforcement directions, or references to litigation.

What the absence of litigation history in the instrument implies for practitioners

• The absence of litigation or case law in the Standard means there is no adjudicated interpretation of the Standard’s terms available inside the instrument itself. Therefore, rights, duties and ambiguous phrases in the Standard must be interpreted against the ordinary statutory text and related Code provisions (not reproduced here), and will remain subject to administrative interpretation by FSANZ and enforcement agencies until tested in courts or tribunals.
• Given the prominence and novelty of cell‑cultured foods as a regulated category, it is possible that contentious factual or legal questions will arise in the future about Schedule 25A entries, the scope of the definition (s 1.5.4,2), or the application of the labelling triggers (s 1.5.4,5 to 7). Those possibilities are not recorded as present in this instrument.

What practitioners should monitor

• FSANZ administrative determinations about Schedule 25A, any guidance documents issued by FSANZ on how to interpret or apply the new Standard, and enforcement activity by agencies in Australian states/territories and New Zealand under the applicable implementing laws. Those materials, rather than the Standard itself, are likely to generate the first wave of interpretative and enforcement questions that could lead to litigation. The Standard itself, as presented, contains no litigation record.

The Standard uses compact language and cross‑references that create a number of practical pitfalls for businesses and advisers. Below are the main issues to watch for, grounded in the Standard’s text.

1. The Schedule gate is binary and decisive (s 1.5.4,3)

• The Standard makes sale conditional on a product being listed in Schedule 25A and on compliance with “corresponding conditions” in that Schedule. If a producer starts commercial supply before the relevant Schedule entry is in place, the product will not meet the permissibility test in s 1.5.4,3. The text does not provide a transitional grace period or grandfathering clause.

2. The definition is organism‑source focused and broad (s 1.5.4,2)

• The definition regulates foods obtained by culturing cells isolated from livestock, poultry, game, seafood (including fish), an egg or an embryo of any of those. The breadth covers a wide range of terrestrial and aquatic animals, and includes embryos and eggs, which may create classification ambiguities for certain novel processes where starting material or derivation is complex. The Standard itself does not resolve borderline cases.

3. Two very narrow permitted descriptors only (s 1.5.4,5(2); s 1.5.4,7(2))

• The Standard allows only the statements “cell‑cultured” or “cell‑cultivated” to be used in conjunction with the ingredient name or the name of the food where required. Synonyms, longer descriptive statements, or marketing representations that do not use these exact words may run afoul of the labelling duty if they purport to substitute for the mandated disclosure.

4. The retail name trigger depends on representations of origin (s 1.5.4,6(1)(d))

• The requirement to include the prescribed statement in the name of a packaged retail food applies only where the food “is represented in words, images or both as being from the animal from which the cell‑cultured food was sourced” (s 1.5.4,6(1)(d)). That creates drafting choices for marketers: avoid explicit representations to escape the name‑of‑food requirement,and yet if the label lacks such representations, Standard 1.2.2 still requires a name that indicates the true nature of the food. The Standard’s example acknowledges this tension. Businesses must be careful not to create representations at other points (advertising, websites, shelf signage) that would trigger the requirement.

The Standard establishes a compact set of compliance actions. Below is a practical, text‑grounded compliance checklist and suggested sequencing based on the Standard’s provisions.

1. Confirm whether your product is a “cell‑cultured food”

• Read the Standard’s definition (s 1.5.4,2): a cell‑cultured food is one obtained by culturing cells isolated from livestock; poultry; game; seafood (including fish); an egg; or an embryo of any of the former. If your process does not involve culturing cells isolated from those sources, this Standard’s obligations will not apply.

2. Check Schedule 25A for permissibility and conditions before marketing

• Do not place a cell‑cultured product on the market until it is listed in Schedule 25A and you can demonstrate compliance with any corresponding Schedule conditions (s 1.5.4,3). The Standard makes sale conditional on being listed. Contact FSANZ or monitor the Gazette/Code updates to confirm listing and to review any product‑specific conditions.

3. Ensure the product is not a Part 2.9 “special purpose food”

• If your product is standardised by Part 2.9 of the Code, you must not add a cell‑cultured food to it (s 1.5.4,4). Check Part 2.9 to confirm whether your intended food falls inside that category.

4. Apply the labelling rules precisely

• Ingredient list: If your food for sale contains a cell‑cultured ingredient, ensure the ingredient’s name is presented “in conjunction with” one of the two authorised statements, “cell‑cultured” or “cell‑cultivated”, as required by s 1.5.4,5(1)-(2). The labelling provisions are governed by Standard 1.2.1, so follow that Standard for placement, legibility and other prescriptive presentation rules.
• Packaged retail name: If the packaged retail product contains a cell‑cultured ingredient and the package is represented in words or images as being from the animal source, include the same statement (“cell‑cultured” or “cell‑cultivated”) in the name of the food (s 1.5.4,6(1)(a)-(d); 6(3)). Ensure the name on the package mirrors the ingredient disclosure wording.
• Non‑retail sales: For packaged cell‑cultured foods sold under Division 3 or 4 of Standard 1.2.1 (for example to caterers), include “cell‑cultured” or “cell‑cultivated” in conjunction with the name of the cell‑cultured food (s 1.5.4,7(1)-(2)).
• Use only the two permitted descriptors: Do not substitute other terms; the Standard limits choices to “cell‑cultured” or “cell‑cultivated” (ss 1.5.4,5(2), 1.5.4,7(2)).