Australia New Zealand Food Standards Code – Schedule 25 – Permitted novel foods

This Schedule lists novel foods that the Australia New Zealand Food Standards Code expressly permits, and it sets conditions for their use. The instrument is a Standard under the Food Standards Australia New Zealand Act 1991 (Cth), and it operates as Schedule 25 , Permitted novel foods to the Code (see Note 1 and S25,1). Mechanically, the Schedule does three things.

First, it identifies specific novel ingredients by name (for example D-allulose; α- and γ-cyclodextrin; diacylglycerol oil; several micro‑algae oil products; isomalto‑oligosaccharide; phytosterols/phytostanols and esters; rapeseed protein isolate; D‑tagatose; tall oil phytosterol esters; trehalose) and records whether they may be sold and the conditions for sale (see S25,2 table). Each table entry is a permission coupled to conditions of use that may be compositional (maximum w/w percentages, per‑serving limits), product‑category limits (only in certain food categories), labelling obligations (ingredient names to appear in the statement of ingredients), or product‑use prohibitions (for example, “must not be added to food for infants”).

Second, the Schedule cross‑references other parts of the Code. Permissions and limits are not self‑contained: they sit alongside or depend upon other Standards and sections of the Code. Examples include cross‑references to Standard 1.5.1 (novel foods generally), Standard 1.2.1 and section 1.2.3,2 (requirements for foods to which phytosterols are added), Standard 2.9.1 (infant formula compositional requirements), and Schedule 3.2 or S3,39(A) for manufacturing or identity specifications (see S25,2 entries and the notes).

Third, the Schedule records time‑limited exclusivities and transitional arrangements. Two permissions include “exclusive use periods” during which only products sold under a specified brand may be sold: D‑allulose is limited to sale under the brand Nexweet for an exclusive use period of 15 months after the relevant gazettal (see S25,2, D‑allulose conditions 6-7); phytosterols/phytostanols/esters have an analogous exclusive use period limited to SANITARIUM HEALTH FOOD COMPANY for beverages (see S25,2, phytosterols condition 8-9). The compilation also includes a transitional clause (Clause 4 in the application/saving/transitional table) establishing a transition period from 13 September 2024 to 13 September 2029 for certain amendments; during that time, products may comply with either the Code as in force before those variations or as amended, and goods labelled before the end of the transition period can be sold after the period if they comply with either version (see the transitional table).

The Schedule commenced initially on 1 March 2016 (S25,1 Commencement note) and has been amended repeatedly; the compilation provided is No. 9 as in force on 29 October 2024 (up to Amendment No. 233) and includes the addition of D‑allulose on 29 October 2024 (Amendment 233) and other changes listed in the Amendment History.

All operative permissions and conditions in this Schedule are directed to enforcing the Code’s framework for novel foods under the Food Standards Australia New Zealand Act 1991. The Schedule does not itself set criminal or civil penalty amounts; it functions as part of the Code that regulators enforce under the enabling Acts and relevant state or territorial legislation, and in New Zealand under the Food Act 2014 where the Code applies or is adopted (see Note 1 and Note 2).

The Schedule operates by a permission model: it lists specific novel ingredients and gives express permissions for particular uses, often with granular limits. The main legal and regulatory concepts to track in the Schedule are:

• Permitted uses with conditionality. Each listed novel food is either permitted or not, and where permitted, the Schedule specifies conditions for use: maximum percentages by weight (w/w) for particular food categories, per‑serving minimums and maximums, or outright prohibitions for certain consumer groups (for example infants). Example: D‑allulose may only be a tabletop sweetener for retail sale and may only be added to a set list of foods, each with a specified w/w limit (S25,2, D‑allulose conditions 1-4).

• Cross‑referencing to other Code Standards. The permissions sit alongside other Code obligations. For example, phytosterols/phytostanols/esters must comply with requirements in Standard 1.2.1 “insofar as they relate to section 1.2.3,2.2” (S25,2). Oil derived from certain micro‑algae is permitted only in infant formula “in accordance with Standard 2.9.1” (S25,2). Rapeseed protein isolate must comply with a specification in section S3,39(A) of Schedule 3 (S25,2, rapeseed entries). Those cross‑references mean compliance with this Schedule typically requires checking multiple Code provisions and Schedule specifications.

• Labelling and ingredient‑naming obligations. Several entries require a specified ingredient name to be used in the statement of ingredients. Examples: “alpha cyclodextrin” or “α‑cyclodextrin” must be used (S25,2, α‑cyclodextrin condition 1); “Diacylglycerol oil” must be used for DAG‑Oil (S25,2). Tall oil phytosterol esters must use the name ‘tall oil phytosterol esters’ or ‘plant sterol esters’ (S25,2). D‑allulose has a specific additional advisory statement requirement: certain foods for sale containing D‑allulose must include an advisory statement that excess consumption may have a laxative effect, per subsection 1.2.3,2(2) (S25,2, D‑allulose condition 5).

• Time‑limited exclusivity mechanisms. Two entries provide exclusive use periods granting sole permitted sale under a named brand for a defined period starting from the gazettal date of the variation: D‑allulose (Nexweet) and phytosterols/phytostanols/esters for a specified beverage application (SANITARIUM HEALTH FOOD COMPANY). Each exclusive use period is defined as 15 months from gazettal (S25,2, D‑allulose conditions 6-7; phytosterols condition 8-9).

• Product‑chain restrictions. The Schedule sometimes prohibits foods containing these novel ingredients from being used as ingredients in other foods. For instance, foods to which phytosterols/phytostanols or their esters have been added must not be used as ingredients in other foods (S25,2, phytosterols condition 4). Tall oil phytosterol esters have a similar restriction (S25,2, tall oil phytosterol esters condition 6).

The Schedule affects multiple actors across the food supply chain. The document itself names product categories, brands and regulatory touchpoints; from that we can identify who bears obligations and who gains or loses commercially.

• Ingredient manufacturers and suppliers. Suppliers of the listed novel ingredients are directly affected because the Schedule determines whether and how their ingredient may be sold into the Australian and New Zealand markets. For example, suppliers of D‑allulose face an immediate restriction: during the 15‑month exclusive use period after gazettal only D‑allulose sold under the brand Nexweet may be a food for retail sale or added to foods in accordance with the Schedule (S25,2, D‑allulose conditions 6-7). Suppliers of phytosterol preparations face an analogous restriction for beverages sold under the SANITARIUM brand for the exclusive period (S25,2, phytosterols condition 8-9).

• Food manufacturers and formulators. Manufacturers who make bakery products, breakfast cereals, confectionery, dairy products, beverages, infant formula, legumes/cereal/nut/seed derived beverages and other specified categories must conform to the numeric and category limits set out in the Schedule. For instance, D‑allulose may only be added to breakfast cereals up to 5% w/w and to non‑alcoholic water based flavoured drinks up to 3.5% w/w (S25,2, D‑allulose condition 4 and condition 5 definition). Phytosterol use in breakfast cereals carries fibre and sugar content thresholds and per‑serving sterol limits (S25,2, phytosterols condition 3).

• Infant formula producers. Several Schedule entries explicitly address infant formula. Oils derived from specific micro‑algae strains are permitted only for use in infant formula products in accordance with Standard 2.9.1 (S25,2 entries for Schizochytrium sp. and Ulkenia sp.). Trehalose is permitted in infant formula products only as a cryo‑preservative for L(+) lactic acid producing microorganisms (S25,2, trehalose). Producers of infant formula must therefore check both the Schedule and Standard 2.9.1.

• Retailers and brand owners. Retailers must ensure that products displayed and sold comply with the Schedule’s permissions and labelling obligations. For D‑allulose and the phytosterols beverage permission, the Schedule gives branded exclusivity which directly affects retailers’ procurement choices: during the exclusive use period retailers may only offer the specified brand (S25,2, conditions 6-9).

• Labelling and compliance officers, quality assurance personnel and R&D teams. The Schedule imposes labelling nomenclature (e.g., required ingredient names) and advisory statements (e.g., D‑allulose laxative warning under subsection 1.2.3,2(2)). Those responsible for labelling and compliance must reconcile the Schedule with other Code obligations and with state/territory enforcement expectations.

The Schedule establishes duties (what actors must do) and rights (what actors may do under specified conditions). Those duties and rights are generally expressed as permissions, prohibitions, compositional limits, naming obligations, exclusive rights and cross‑reference obligations.

Duties (requirements)

• Observe product‑category limits and maximums. Where the Schedule sets a w/w or per‑serving limit, manufacturers must ensure the final food product does not exceed that limit. Examples: D‑allulose limits for individual food categories (e.g., 5% w/w for breakfast cereals, 3.5% w/w for non‑alcoholic water based flavoured drinks, 100% for tabletop sweeteners) (S25,2, D‑allulose condition 4). Phytosterol breakfast cereal use requires fibre not less than 3 g/50 g and sugars not more than 30 g/100 g and total plant sterol equivalents between 0.5 g and 2.2 g per serving (S25,2, phytosterols condition 3).

• Comply with referenced Standards and specifications. Where the Schedule refers to other Standards (e.g., Standard 2.9.1 for infant formula, Standard 1.2.1 for phytosterols, Schedule 3.2 or S3,39(A) for ingredient specifications), the duty is to meet those requirements as well as this Schedule’s conditions (S25,2 cross‑references).

• Label using specified ingredient names and include required advisory statements. Several items require the stated ingredient name to appear in the statement of ingredients: α‑cyclodextrin, γ‑cyclodextrin, Diacylglycerol oil, tall oil phytosterol esters/plant sterol esters (S25,2). D‑allulose requires an advisory statement for certain foods that excess consumption may have a laxative effect, linked to subsection 1.2.3,2(2) (S25,2, D‑allulose condition 5).

• Observe category exclusions. For example, isomalto‑oligosaccharide must not be added to food for infants or formulated supplementary food for young children (S25,2, isomalto‑oligosaccharide entry). Rapeseed protein isolate must not be added to food for infants (S25,2, rapeseed protein isolate condition 2).

• Do not use certain fortified foods as ingredients. Foods to which phytosterols/phytostanols/esters or tall oil phytosterol esters have been added must not be used as ingredients in other foods (S25,2, phytosterols condition 4; tall oil phytosterol esters condition 6).

Rights (permissions)

• Sell and add listed novel foods within the permitted categories and limits. The Schedule grants permissions to add novel foods to particular product categories subject to the conditions stated. E.g., authorised addition of Schizochytrium‑derived oils to infant formula in accordance with Standard 2.9.1 (S25,2).

The Schedule itself does not state civil or criminal penalty amounts or enforcement procedures. Instead, it is a Standard under the Food Standards Australia New Zealand Act 1991 and the Code it forms part of is enforced under that Act in Australia and is incorporated/adopted under New Zealand’s Food Act 2014 (Note 1 and Note 2). Therefore, enforcement and penalties are governed by the enabling legislation and by state and territorial food laws and enforcement frameworks in Australia, and by New Zealand law where the Code applies.

What the Schedule does make enforceable

• The Schedule’s permissions and conditions (for example the maximum w/w limits for D‑allulose in specified foods, naming obligations, prohibitions such as “must not be added to food for infants” for rapeseed protein isolate) form part of the Code. Non‑compliance with those Code requirements is, in practical effect, non‑compliance with the regulatory framework that enforcement agencies apply. Practitioners should therefore treat the Schedule’s conditions as obligations subject to enforcement action administered under the Food Standards Australia New Zealand Act and complementary state/territory statutes.

• Exclusive use conditions are regulatory constraints. If a person or business sells D‑allulose or D‑allulose‑containing foods for retail sale during the exclusive use period other than under the specified brand Nexweet, they will be selling in a manner inconsistent with S25,2 conditions 6-7. The Schedule does not itself set a unique penalty for that breach; enforcement action would be taken using the enforcement powers in the relevant Act and regulations.

Who enforces

• Federal standard‑setting versus local enforcement. FSANZ is the standard setter for the Code; enforcement is typically executed by state or territory food regulatory agencies in Australia and by the relevant authority under the Food Act 2014 in New Zealand (Note 2). The Schedule indicates which provisions apply in New Zealand by reference to the Food Act 2014 but does not convert FSANZ into an enforcement agency for offences under the Code.

Practical implications for enforcement and compliance risk

• Multi‑jurisdictional enforcement. Because the Code is a national instrument adopted across jurisdictions, enforcement can occur in multiple places; for businesses operating across states or into New Zealand, compliance failures may lead to enforcement actions in each jurisdiction where breaches occur. The Schedule’s cross‑references to other Standards mean enforcement may require compositional analysis (analytical testing), label review, and documentary checks against manufacturer specifications (e.g., S3,39(A) for rapeseed protein).

The Schedule is embedded within the broader Code and interacts with other Standards, Schedules and with the enabling Acts in both Australia and New Zealand. The instrument itself cross‑references multiple Code provisions; those cross‑references are the primary legal interaction points.

Direct cross‑references inside the Code

• Standard 1.5.1 and the novel foods framework. The Schedule lists permitted novel foods and conditions “for section 1.5.1,3” (S25,2 header). The Note at the top of the Schedule explicitly ties novel food regulation to paragraphs 1.1.1,10(5)(b) and (6)(f) and Standard 1.5.1. Practically, this means any assessment or compliance review of a novel food permission must be undertaken alongside the obligations in Standard 1.5.1 and the introductory provisions of the Code.

• Standard 1.2.1 and section 1.2.3,2. The phytosterols/phytostanols/esters entries require compliance with Standard 1.2.1 “insofar as they relate to section 1.2.3,2.2” and refer to labelling/advisory regimes in section 1.2.3,2 where applicable (S25,2). D‑allulose also references subsection 1.2.3,2(2) for the advisory statement on laxative effects (S25,2, D‑allulose condition 5).

• Food category Standards. The Schedule refers to product Standards for specific food categories: Standard 2.9.1 for infant formula products (multiple entries), Standard 2.4.2 for edible oil spreads where phytosterols may be added, Standard 2.5.1 for milk and 2.5.3 or 2.5.4 for yoghurt and cheese categories where phytosterols or tall oil esters may be added (S25,2 entries). These interactions mean permission to include the novel food is conditional on meeting the compositional and labelling rules in the product Standard.

• Schedule 3 specifications. Several entries require compliance with Schedule 3 chemical/identity specifications. For example, tall oil phytosterol esters must comply with the schedule 3.2 specification and rapeseed protein isolate must comply with S3,39(A) (S25,2). Those specifications may impose technical identity, purity or contaminant limits.

Interaction with enabling Acts and territorial law

• Standard under FSANZ Act 1991. Note 1 establishes that this Schedule is a Standard under the Food Standards Australia New Zealand Act 1991 (Cth). That Act is the statutory basis for the Code and for FSANZ’s functions, and it establishes the process for making, amending and gazetting Standards (see commencement note and amendment history which reference section 92 and 93 of the Act).

The compilation provided is No. 9 of Schedule 25 as in force on 29 October 2024, and it includes any commenced amendments affecting the compilation to that date (the compilation statement at the end of the Schedule). The Schedule sets out a detailed Amendment History (a table summarising amendments). Key entries in that Amendment History include:

• Original publication and commencement. Schedule 25 was published in the Food Standards Gazette No. FSC96 on 10 April 2015 as part of Amendment 154 (F2015L00440 , 1 April 2015) and commenced on 1 March 2016 per S25,1 (commencement note).

• Subsequent additions and amendments. The Amendment History records a sequence of amendments (Amendment numbers and FRL registration/Gazette references). Select amendments that materially changed the Schedule include:

  • Amendment No. 168 (F2017L00414), 13 April 2017: a cross‑reference amendment to Note 1 of the Standard.
  • Amendment No. 170 (F2017L00586 and F2017L00584), 25 May 2017: additions to include oil derived from marine micro‑algae Schizochytrium sp. (ATCC PTA‑9695) and to amend the phytosterols entry.
  • Amendment No. 171 (F2017L00915), 13 July 2017: addition of isomalto‑oligosaccharide.
  • Amendment No. 139 (F2021L00324), 30 June 2021: addition of rapeseed protein isolate.
  • Amendment No. 200 (F2021L00684), 3 June 2021: an amendment to the phytosterols entry (timing shows overlapping registry entries).
  • Amendment No. 215 (F2023L00032), 16 January 2023: further addition relating to phytosterols, phytostanols and esters.
  • Amendment No. 220 (F2023L01004), 19 July 2023: Amendment that repealed the rapeseed protein isolate entry and substituted it (the Amendment History shows “rs” meaning repealed and substituted).
  • Amendment No. 231 (F2024L01151), 13 September 2024: a set of repeals and substitutions, notably repealing several table entries for marine micro‑algae oils and substituting updated conditions; this amendment also introduced the transitional Clause 4 establishing a five‑year transition period from 13 September 2024 to 13 September 2029 for variations made by certain items (application/saving/transitional table).
  • Amendment No. 233 (F2024L01377), 29 October 2024: insert D‑allulose and associated conditions of use into the S25,2 table (this is the most recent addition in this compilation).

• Transitional arrangements. The application/saving/transitional table explicitly describes a transition period of five years for certain variations commencing on 13 September 2024 and ending 13 September 2029 (Clause 4). That clause clarifies that during the transition period section 1.1.1,9 of the Code does not apply to the variations, and products may either comply with the Code as in force without those variations or with the amended Code (application/saving/transitional table). It also allows goods labelled before the transition’s end to be sold after the transition period if they comply with either version.

The Schedule as compiled does not record any litigation. It is a regulatory instrument created and amended under the Food Standards Australia New Zealand Act 1991 and the compilation includes an Amendment History, application/saving/transitional provisions and the list of permitted novel foods with their conditions, but contains no case law, court decisions or references to legal proceedings.

What that means in practice

• No Schedule‑level cases recorded. The document does not list enforcement or judicial decisions concerning Schedule 25. The absence of litigation entries in the Schedule should not be taken to mean there have been no disputes or enforcement actions under the Code generally; it only means the Schedule does not itself include or summarise litigation.

• Where litigation would record. Any cases or formal administrative decisions that interpret or enforce Schedule 25 obligations would appear in external sources such as court judgments, administrative tribunal decisions or enforcement agency records, not in the Schedule compilation. Practitioners needing precedential or interpretive guidance must therefore search judicial and tribunal databases and enforcement agency publications rather than rely on the Schedule for litigation history.

• Administrative review and enforcement avenues. While no litigation is recorded in the Schedule, enforcement actions for breaches of the Code’s Standards are taken under the relevant Acts and by enforcement agencies. Any contested enforcement actions (for example, recalls, notices, fines or prosecutions under state/territory food laws or under the relevant national law) would be the material for litigation or administrative review.

If a practitioner requires case law or administrative decisions interpreting any of the Schedule’s provisions (for example the effect of an exclusive use period, the operation of the transition clause, or the meaning of a product category definition), the Schedule itself provides the statutory text but not the interpretive history. Research beyond the Schedule will be necessary to locate any relevant litigation or agency rulings.

Schedule 25 contains several discrete provisions and mechanisms that can be easily missed or misinterpreted. These are practical “gotchas” that create compliance or commercial risk if overlooked.

1. Exclusive use periods tied to named brands. Two Schedule entries grant exclusive use for 15 months after gazettal to named brands: D‑allulose to Nexweet and certain phytosterol beverage permissions to SANITARIUM HEALTH FOOD COMPANY (S25,2, D‑allulose conditions 6-7; phytosterols condition 8-9). The mechanism is literal: “only D‑allulose sold under the brand Nexweet may be a food for retail sale” during the exclusive use period. Practitioners often assume an ingredient permission means anyone may market it once permitted; here the Schedule creates a temporary, legislated exclusivity. Businesses should check the exact gazettal date to determine the exclusive period window. The exclusive use condition applies to sale “as a food for retail sale” and to addition in accordance with conditions 2-5 for D‑allulose, so importers and manufacturers should not assume immediate open market access.

2. Advisory statement for D‑allulose linked to another provision. The D‑allulose entry requires an advisory statement on laxative effects under subsection 1.2.3,2(2) for certain foods (S25,2, D‑allulose condition 5). The Schedule does not itself spell out the wording; it cross‑references subsection 1.2.3,2(2). If practitioners miss the cross‑reference, they may fail to include the required advisory statement.

3. Definition traps for beverages. D‑allulose condition 5 defines “non‑alcoholic water based flavoured drink” with an inclusion list and an exclusion list. The exclusion list specifically excludes drinks standardised in Part 2.9 of the Code, dairy analogues, fruit juices, vegetable juices, formulated beverages, electrolyte drinks, and electrolyte drink bases (S25,2, D‑allulose condition 5). A product that appears to be a soft drink might fall into an excluded category depending on how it is classified under the Code, which would affect whether the D‑allulose limit applies.

4. “Must not be used as ingredient in other foods” prohibitions. For phytosterols and tall oil phytosterol esters, the Schedule bars foods to which they have been added from being used as ingredients in other foods (S25,2, phytosterols condition 4; tall oil condition 6). That restricts food chain uses and must be observed to avoid non‑compliant downstream products.

5. Per‑serving versus percentage limits. Some limits are per serving and some are percentage w/w. For phytosterols, per‑serving plant sterol equivalent limits apply (no less than 0.5 g and no more than 2.2 g per serving for breakfast cereals) while other products have percentage limitations (D‑allulose bakery products 10% w/w) (S25,2). Misapplication of the correct metric is a common compliance error.

Compliance with Schedule 25 requires a structured, evidence‑based approach because permissions are rarely unconditional. Below are practical steps grounded in the Schedule text and its cross‑references.

1. Confirm the applicable legal version and relevant dates. Check the compilation date (this compilation is as in force on 29 October 2024) and the Amendment History to identify the commencement date of the relevant variation (see Amendment History table). Where there is an exclusive use period tied to a gazettal date (for example D‑allulose and phytosterols), determine the gazettal date and calculate the 15‑month exclusive period (S25,2, conditions 6-9). Also identify whether the Clause 4 transitional arrangement applies (it applies to variations commencing 13 September 2024, providing a transition window to 13 September 2029 for those specified variations).

2. Map your product into the Schedule’s categories and limits. For any product containing a novel ingredient:

   • Identify the exact product category used in the Schedule (e.g., bakery product, breakfast cereal, non‑alcoholic water based flavoured drink).
   • Apply the corresponding compositional limits (percentage w/w or per serving limits) listed in S25,2.
   • Verify if there are any additional compositional thresholds you must meet (for example the breakfast cereal fibre and sugar thresholds for phytosterol addition) (S25,2, phytosterols condition 3).

3. Check cross‑referenced Standards and Schedule specifications. The Schedule repeatedly cross‑references other Code provisions (for example Standard 1.2.1, Standard 1.5.1, Standard 2.9.1, Schedule 3.2, S3,39(A)). You must ensure compliance with those provisions as they are incorporated into the permission. For infant formula applications, confirm compliance with Standard 2.9.1 as referenced (S25,2).

4. Meet labelling and ingredient naming obligations. Use the exact ingredient term required in the statement of ingredients where the Schedule specifies it (e.g., “alpha cyclodextrin” or “α‑cyclodextrin”, “Diacylglycerol oil”, “tall oil phytosterol esters” or “plant sterol esters”) (S25,2). For D‑allulose, include the advisory statement required by subsection 1.2.3,2(2) where applicable (S25,2, D‑allulose condition 5). Ensure that the label language and placement meet the Code’s broader labelling rules.

5. Respect prohibitions on downstream use. If the Schedule states foods containing the novel ingredient must not be used as ingredients in other foods (phytosterols and tall oil esters), prevent their inclusion in composite products or ingredient supply chains to avoid inadvertent non‑compliance (S25,2).