Novel foods in Australia: when a new ingredient needs FSANZ approval

What makes a food novel

The Code's definition works in two steps. First, a non-traditional food is:

• a food that doesn't have a history of human consumption in Australia or New Zealand;
• a substance derived from a food, where the substance has no such history other than as a component of that food; or
• any other substance, where neither it nor its source has a history of human consumption as a food in Australia or New Zealand.

Second, a non-traditional food is novel if it "requires an assessment of the public health and safety considerations", having regard to the potential for adverse effects in humans, its composition or structure, how it was prepared, its source, the patterns and levels of its consumption, or any other relevant matters.

So an extract of a familiar food can be non-traditional when the food itself isn't, and a non-traditional food is only novel if its safety needs assessing. Use in a food for special medical purposes doesn't count as a history of human consumption.

The rule follows from that. Unless the Code expressly permits it, a food for retail sale must not be a novel food. Standard 1.5.1 gives the permission: a retail food may be or contain a novel food listed in the table in Schedule 25, as long as the conditions of use in its row are met, and an infant formula product only if the table expressly permits it. Those conditions can name the brand it may be sold under for its first 15 months.

How to tell if an ingredient is novel

There is no simple register to check. FSANZ suggests three routes:

• Its guidance tool, which weighs the length, extent, quantity and purpose of an ingredient's use as food. As a general guide, it says 2 to 3 generations would be a long period of use, and 5 years or less a short one.
• Advice from a food consultant, or legal advice.
• The record of views of its Advisory Committee on Novel Foods (ACNF): a table of the committee's views on whether foods it was asked about are novel. In its September 2026 edition, for example, the committee's view is that freeze-dried miracle berry powder is a novel food, as its safety isn't established.

None of these is a ruling. FSANZ says the record of views is "not legal advice" and not legally binding, isn't a decision by FSANZ, and isn't a safety assessment. Whether a food is novel is "ultimately the responsibility" of the agencies that enforce the Code: in Australia, state and territory agencies and local councils, and the Department of Agriculture, Fisheries and Forestry at the border. And while the ACNF is under review, it "is not considering new enquiries".

Applying to FSANZ

Anyone who wants to sell a novel food, or a food containing one, must apply to FSANZ to have it listed in Schedule 25, and the application goes through "a statutory assessment which includes a pre-market safety assessment". FSANZ encourages applicants to contact it before applying.

1. Acceptance. FSANZ has 15 business days to accept or reject an application. It also decides then which procedure applies (general, minor, major or high level health claim variation), mainly by the kind of change sought, and, for a paid application, the charge level, from the estimated hours of work.
2. Assessment. For a novel food, FSANZ considers "a variety of toxicological and nutritional issues together with information about its chemistry and how much of it we expect people to eat", and drafts the change to the Code.
3. Consultation. Generally for six weeks.
4. The Board's decision. Counted from the start of the assessment, and not counting time spent waiting for information, FSANZ's Board must decide within 9 months under the general procedure, 3 months under the minor procedure or 12 months under the major one, which can be extended by up to 6 months.
5. The Food Ministers. They have 60 days to ask FSANZ to review the change, or to tell FSANZ they won't. They can only amend or reject it after a review.
6. Gazettal. Generally within two weeks of the Ministers' decision. From then, the food can be sold within the conditions of its listing.

Once accepted, an unpaid application waits for its assessment to start: FSANZ's August 2026 work plan puts the wait at about 12 months, and an applicant can pay to bring the start forward.

What FSANZ charges

FSANZ doesn't charge for assessing an application unless:

• it decides the applicant has an exclusive capturable commercial benefit (ECCB): broadly, the applicant stands to gain financially from the change to the Code, and others would need its agreement to benefit from it. FSANZ's own example is a novel food application that asks for an exclusive permission; or
• the applicant wants the assessment to start immediately, rather than when FSANZ would reach it.

For applications made since 1 October 2025, a paid application costs a fixed charge of $23,697 plus a variable charge set by the estimated hours of work: $25,180 for up to 180 hours, rising to $113,320 or more for a major procedure. With FSANZ's $750 administration charge, that runs from $49,627 for the smallest general procedure to $137,767 or more for a major one. Applications under the minor procedure aren't charged. FSANZ proposed no fee changes for 2026–27.

Up to 15 months of exclusive use

An applicant can ask for its permission to be exclusive "for up to 15 months". FSANZ usually only considers it if the applicant expressly applies for it, and decides whether to grant it against set criteria. Schedule 25 then ties the novel food to a brand, or a class of food, for up to 15 months after gazettal: plant-based drinks with added plant sterols, for example, could "only be sold under the brand SANITARIUM HEALTH FOOD COMPANY" during their exclusive use period. After that, "the permission becomes generic and non-brand specific", and the food can be sold under any brand within its conditions.

Exclusivity doesn't stop a competitor applying. FSANZ says nothing in its Act or the Code prevents it approving the same novel food for another company, under a different brand, within the 15 months. And asking for it makes the application one FSANZ is likely to charge for.

Other approvals a new ingredient might need

Not every new ingredient is a novel food question. The Code has other routes, each needing FSANZ's approval:

• Food additives. FSANZ assesses their safety before they can be used, and the permitted ones are listed in Standard 1.3.1.
• Processing aids. A food can't contain a substance used as a processing aid unless the Code permits it, under Standard 1.3.3.
• Nutritive substances. A vitamin, mineral or other listed substance added to a food to achieve a nutritional purpose needs the Code's permission too. Unless another part of the Code allows it, a vitamin or mineral can only be added to the foods Schedule 17 lists for it, in a permitted form and within any limit.
• Genetically modified food. Standard 1.5.2 requires pre-market approval, including a food safety assessment, and labelling.
• Cell-cultured food. A newer route: Standard 1.5.4 and Schedule 25A, made in June 2025 with the approval of cultured quail.

Recent decisions

• Moringa, rejected. In November 2025 FSANZ rejected an application to permit Moringa oleifera as a novel food: the information "was not sufficient to establish the safety" of its leaves, immature seed pods and oil. FSANZ notes that therapeutic products containing it are regulated separately by the TGA.
• Cell-cultured duck, approved. FSANZ approved it on 6 October 2026, and the Food Ministers then have 60 days to consider it.
• New applications. Among them, Rhizomucor pusillus mycelium as a novel food, accepted on 17 September 2026 under the general procedure, and Rhiza mycelium (Neurospora crassa) biomass.
• The rules themselves. FSANZ's review of how novel foods and nutritive substances are regulated is on hold, pending the review of the FSANZ Act.

Food or medicine?

The novel food rules are for foods. Whether a product is a food or a medicine turns mainly on whether it is presented as, or likely to be taken to be, for therapeutic use, and whether it has been declared a therapeutic good, and our food pathway covers the line. As a listed medicine, a supplement's ingredients come from the TGA's Permissible Ingredients Determination instead, and an ingredient that isn't in it needs an application to the TGA: see our new ingredients guide.

Where we come in

When a brand wants an ingredient that may be novel in a food, we check it before the formula is fixed: its history of use, the record of views, and whether the product should be a food or a listed medicine at all. If it would need FSANZ's approval, we'll tell you what that involves, then manage the application (new ingredient applications) or find a permitted alternative. Our own brand, Ora, sells premium functional foods beside its listed medicines. More on supplements as foods and formulation, or book a call.