Food Standards Australia New Zealand accepted application A1364 on 24 August 2026. The application asks FSANZ to permit whole Neurospora crassa biomass, sold by BMC Ingredients as Rhiza mycelium, as a novel food. The regulator’s own timeline puts gazettal in mid-June 2028 if no one requests a review. That is roughly 22 months from acceptance, and about twelve of those months, on FSANZ’s own estimate, pass before assessment work even starts.
For an operator planning Australian or New Zealand volume, the practical reading is simple. Nothing in the paperwork we reviewed states that the safety case is the obstacle. On the regulator’s own estimate, the date is driven by when FSANZ expects to start work.
This piece is a follow-up. The company’s US, Canadian and capacity story, including its pricing target, is in our earlier analysis, BMC Ingredients’ Rhiza price target slips to 2027. We do not restate it here.
What FSANZ has actually published
The application appears in Notification Circular 413-26, published 29 September 2026 under the heading General procedure. The circular lists the title as “A1364 - Rhiza mycelium (Neurospora crassa) biomass as a novel food” and gives the date accepted as 24 August 2026. The circular page text we retrieved does not name the applicant. It states: “An opportunity to comment will be available at a later date, which will be publicly notified.”
The Administrative Assessment Report, dated 29 September 2026, supplies the rest. The applicant is BMC Ingredients. The application was received on 3 August 2026 and the administrative assessment was completed on 24 August 2026, the day it was due. The report lists a notification date of 28 September 2026, one day before the circular’s publication date. We treat the circular date as the public date and note the one-day difference only because anyone building a compliance calendar will see both.
The procedure is General Level 4 with a maximum of 520 total variable hours. FSANZ’s stated reason is that the application “Requires a toxicological, nutritional, food technology and dietary modelling assessment of greater than average complexity”. Potentially affected schedules are 3 and 25.
| Milestone | FSANZ’s estimate for A1364 |
|---|---|
| Application received | 3 August 2026 |
| Application accepted | 24 August 2026 |
| Notification circular | 29 September 2026 |
| Assessment start (clock start) | Late August 2027 (report also gives “August 2027” as estimated start) |
| Public comment, proposed 8 weeks | Early December 2027 to late January 2028 |
| Board consideration of approval | Late April 2028 |
| Notification to Food Ministers’ Meeting | Early May 2028 |
| Anticipated gazettal, if no review requested | Mid June 2028 |
Practical consequence: treat mid-June 2028 as the earliest date on which an Australian or New Zealand product claim could rest on a Schedule 25 listing, and treat any earlier date as unsupported by the regulator’s own document.
The queue is the finding
Take the dates at face value. Acceptance is 24 August 2026. Assessment start is late August 2027. That is about twelve months in which, on FSANZ’s own estimate, the clock has not started. From the clock start to the anticipated gazettal is about nine to ten months. The wait before the work is longer than the work.
The administrative report does not say why the start is a year out. It gives the estimate and the procedure level, and that is all we can read from it. Our inference is that the start date reflects the order in which accepted applications are taken up, but that is an inference. What the document does establish is the sequence of dates, and the sequence is what a planner needs.
The comparison with the one other FSANZ novel food file we could read in full is instructive. A1341, the cell-cultured duck application covered in our piece on the second cell-cultured application and the inherited framework, was run on General Level 5 with a 693-hour ceiling. Its administrative report shows a very different gap between acceptance and the start of work.
| Measure | A1341 (cell-cultured duck) | A1364 (Rhiza mycelium) |
|---|---|---|
| Date received | 13 August 2025 | 3 August 2026 |
| Date accepted | 11 September 2025 | 24 August 2026 |
| Procedure | General, Level 5 | General, Level 4 |
| Maximum total variable hours | 693 | 520 |
| Estimated assessment start | Early October 2025 | Late August 2027 |
| Public consultation in the estimate | Early March 2026 (six-week period) | 8 weeks, early December 2027 to late January 2028 |
| Board consideration | Early June 2026 | Late April 2028 |
| Anticipated gazettal, if no review | Late August 2026 | Mid June 2028 |
Our own arithmetic on these published estimates: A1341 was forecast to start about three to four weeks after acceptance and to reach gazettal in roughly eleven to twelve months. A1364 is forecast to start about twelve months after acceptance and to reach gazettal in roughly twenty-two. The smaller file, with 173 fewer hours at its ceiling, has the longer total. The active assessment window is not what is longer. The queue is.
Practical consequence: when you compare regulatory routes, compare the accepted-to-start gap separately from the assessment duration. Only the second one reflects the dossier.
What BMC has told FSANZ
The Executive Summary is the applicant’s account of the ingredient, and it is useful mainly because it shows which evidence the company chose to lead with.
On scope, the proposed uses are “Meat/dairy analogues, hybrid meat products, protein blends and bars, pasta, baked goods, soups, snacks and composite foods” at “use levels 15–90% (dehydrated basis)”. The listing sought is in Schedule 25. The summary says the approval “would list the ingredient in Schedule 25 (Permitted Novel Foods)” and that “the requested Schedule 25 listing is a generic permission available to any party meeting the specification.” It adds that BMC “does not seek exclusive-use permission or an exclusive capturable commercial benefit”. For competitors, that is the line that matters: if the application succeeds, the permission is not BMC’s alone, provided another producer’s biomass meets the specification.
On other regulators, the summary cites the FDA’s “no questions” letter on GRN 1117 dated 9 July 2024, Singapore Food Agency approval in October 2024 and a Health Canada “letter of no objection” in July 2026. Those are consistent with what we found elsewhere. FDA’s inventory page shows the closure date as 9 July 2024 and the response as “FDA has no questions” (linked as a PDF). Green Queen reported the Singapore approval on 18 October 2024 and said the FDA letter came about three months before it. Green Queen’s Canada report was published 28 July 2026, which fits the summary’s July 2026 date. Neither Canadian article gives a date for the letter itself, so “July 2026” rests on the applicant’s summary and the publication dates of the news reports.
The safety package as summarised includes a 90-day rat study with a “NOAEL of 5,000 mg/kg bw/day—the highest dose tested”. That wording matters: a NOAEL at the highest dose tested means no adverse effect was seen at any dose, so the study did not find the upper bound. The summary also says N. crassa “has no known mycotoxin-coding genes” and that “three lots tested non-detect for all common mycotoxins”. For purines, the worst-case 90th-percentile intake is given as approximately 0.46 g/day against a 2 g/day reference limit.
The exposure figures are for the United States and Canada. For the US the mean is 14 g/day dry and the 90th percentile 33 g/day dry. For Canada the mean is 15 g/day dry and the 90th percentile 35 g/day dry. The summary cautions: “These estimates reflect consumers of the target food categories rather than the whole population, and are therefore conservative”. FSANZ has said it needs dietary modelling, so we would expect Australian and New Zealand consumption data to enter the assessment, but the summary we read does not present them.
Practical consequence: if you formulate at the top of the proposed range, the specification and the dehydrated-basis convention are what you will be held to, not the US GRAS basis. Check your own use levels against the dehydrated basis before you size an Australian launch.
A date that does not line up
The FSANZ summary states: “Rhiza™ mycelium has been sold in the United States since 2021.” The GRAS notice for the same ingredient, as posted by FDA, carries a cover letter dated 30 September 2022. In our reading of that document it reports no BMC sales history. It says BMC intends to market the ingredient and cites historical food uses of Neurospora such as Indonesian oncom and Brazilian tiquira, which are not BMC sales. FDA’s inventory page lists the closure date, 9 July 2024, but not a filing date, so the 2022 date comes from the notice itself.
On their face the two documents are in tension. A 2021 sales start would precede a 2022 notice that speaks of intended marketing. There are plausible reconciliations. The 2021 figure might refer to earlier or differently formulated product, or to pre-commercial supply. The notice may not have been written to catalogue sales. We cannot tell which, and we did not find any BMC statement that resolves it. We also read the notice through a summarising fetch, not a line-by-line reading of the full PDF, so the absence of a sales history in it is a reading, not a proven negative.
Why it matters: our inference is that an inconsistent history-of-use date is the kind of detail an assessor could query. We are not saying the discrepancy will cost time. We are saying it is a discrepancy in the public record that the applicant can easily fix, and that anyone relying on “sold since 2021” as a track-record claim should check the source.
Practical consequence: do not repeat the 2021 figure in your own supplier files without asking BMC what it refers to.
How this sits against the company’s own plan
BMC’s commercial calendar runs ahead of the Australian one. In its Canada coverage, Green Queen quotes CEO Paul Shapiro: “We intend to be producing large-scale commercial volumes of Rhiza mycoprotein starting within Q2 2027”. The same report says a contract manufacturer in Asia is due to open in Q2 2027 with capacity of 100 dry tonnes per month. The vegconomist report likewise gives second quarter 2027 as the expected availability of large commercial volumes. Details of the plant and pricing are in our earlier analysis.
Set against FSANZ’s estimate, an Asian plant in Q2 2027 would be producing for roughly twelve to fourteen months before the anticipated gazettal in mid-June 2028. That is our arithmetic on two published dates, and both are forecasts. During that window BMC will be able to supply markets that have already cleared it. Singapore is one of them, and our record of how that regulator publishes its approvals is in our review of the SFA novel foods list. Australia and New Zealand will not be.
Regulatory clocks elsewhere are covered in our piece on China’s first mycoprotein approval and its capacity. Whether any alternative mycoprotein matches Rhiza on function is a separate question, which we examined in our look at mycoprotein functionality data. Because the Schedule 25 listing would be generic, a later FSANZ listing is not tied to BMC’s own supply either.
Practical consequence: Australian and New Zealand buyers who want Rhiza in 2027 are looking at a gap of about a year in which supply exists but the permission does not.
The counter-argument
There are four reasonable objections to the claim that the queue sets the date.
First, the timeline is an estimate, not a commitment. FSANZ’s administrative report for A1364 gives “estimated” and “anticipated” dates. The A1341 file may show that they can move. Its administrative report estimated public consultation for “Early March 2026”, yet FSANZ’s news item of 16 July 2026 describes consultation on A1341 as open, with a closing date of 22 July 2026. We do not know whether that was a delayed first consultation or a different step, and the news page does not state the consultation’s opening date. But if the A1341 forecasts did slide by months, A1364’s could slide too. That cuts against the idea that mid-June 2028 is a safe planning date, and it would be a reason to plan later, not earlier.
Second, the “queue” may be a reasonable allocation of a finite resource. A regulator working to hour ceilings and a set of statutory duties has to order its files. A year’s wait for a Level 4 application is not evidence of neglect. It may reflect a rational choice to put higher-priority or larger files first. We have no document that states FSANZ’s prioritisation rules, so we cannot call the ordering unreasonable. We only say it determines the date.
Third, BMC may not need Australia soon. The company’s own stated priority is large-scale volume from the Asian plant starting in Q2 2027, and the markets it has already cleared are in North America and Singapore. A mid-2028 Australian listing could be commercially fine for a company that, in our inference, may not yet be able to supply every market it has cleared. On that reading the queue costs little.
Fourth, the science may still be the swing factor. A General Level 4 file with a 520-hour ceiling is a defined scope, but if the assessment turns up a question, such as the sales history above or Australian consumption patterns, the active phase could run longer than nine or ten months. The clean timeline assumes a clean file. We are describing the dates FSANZ has put in writing, not predicting the outcome.
Our view is that none of these overturns the central point. Even if the dates slide, the structure of the timeline is that most of the schedule before the public comment is waiting, and the safety package is not the stated reason for that.
Practical consequence: plan on mid-2028 as a best case. If your Australian launch depends on it, hold a contingency of at least a quarter.
What we could not establish
- Why the assessment start is August 2027. The administrative report states the date but not the reasoning, and we found no FSANZ document that sets out how it sequences accepted applications.
- The meaning of “sold in the United States since 2021”. It conflicts on its face with a 2022 GRAS notice that reports no sales. We found no BMC statement reconciling the two.
- The date of the Health Canada letter. Neither the Green Queen nor the vegconomist report gives it. The applicant’s summary says July 2026.
- The date GRN 1117 was filed with FDA. The inventory page does not list a filing date. The only date we can tie to the notice is its 30 September 2022 cover letter.
- Whether any application for Rhiza or whole Neurospora crassa biomass is pending in the EU or the UK. Searches turned up none, but absence from search results is not proof that none exists, so we say nothing further on either.
- Whether the A1341 consultation we found dated July 2026 is the first or a later consultation for that application. We also could not retrieve FSANZ’s own A1341 application page.
- Australian and New Zealand exposure estimates. The summary gives US and Canadian figures only.
What to watch
These are claims you can test against FSANZ’s own publications.
- FSANZ will publish a public consultation on A1364 with an opening between early December 2027 and late January 2028 and a length of 8 weeks. A slip beyond the end of January 2028 would show the start date moved.
- The assessment will start in August 2027 on the administrative report’s estimate. A later start date appearing in an updated FSANZ work plan is the earliest sign the mid-2028 date is at risk.
- The Board will consider approval in late April 2028 and the Food Ministers’ Meeting will be notified in early May 2028. If either is missing in the public record by the end of May 2028, our inference is that mid-June gazettal is unlikely.
- The listing, if granted, will be a generic Schedule 25 entry with no exclusive-use element, as the executive summary says BMC is seeking. Watch whether the final specification text allows another producer’s biomass to qualify.
- BMC will state what its “since 2021” claim refers to, or FSANZ’s later documents will change it. Watch the draft assessment for the sales-history wording.
- BMC’s contract plant in Asia will open in Q2 2027. If it does, expect roughly a year of supply with no Australian permission. If it slips, the gap narrows.