In July 2024, Leprino Foods — the world’s largest mozzarella manufacturer — signed what both parties called an exclusive agreement with the Dutch startup Fooditive Group to commercialise precision-fermented casein worldwide.
The word “exclusive” is doing less work than it appears to. The joint announcement is specific: “Leprino Foods will have exclusive worldwide rights to market and distribute for use in cheese and a non-exclusive worldwide license to market and distribute for all other food applications”.
Exclusive in cheese. Non-exclusive in beverages, yogurts, desserts, creamers, snack bars and sports nutrition. That single sentence is the most informative thing published about how this category will be structured, and it is worth reading carefully before assuming that a big-dairy partnership takes an ingredient off the board.
Why casein, and why it is harder
We have covered what changes when a formulator switches to a fermentation-derived protein — the β-lactoglobulin and ovalbumin case. Casein is a different problem, and the people building it say so plainly.
Inja Radman, co-founder and chief scientific officer of New Culture, told FoodNavigator in July 2026: “Producing casein via precision fermentation is very difficult technologically, much more difficult than whey. This is reflected in both the patent space and the commercial traction we see”. Yvan Chardonnens, chief executive of Standing Ovation, put the same point in geographic terms to AgFunderNews in March 2026: “We are also focused on casein, which is the North Face of precision fermentation, whereas a lot of competitors decided to go for [the whey protein] beta-lactoglobulin, as that is easier [to make].” The bracketed clarifications are AgFunderNews’s, not ours.
The functional prize is why anyone bothers. Fooditive’s own technical page states that its technology “replicates the unique casein micelle structure, which is essential for providing the body, texture, and the hallmark melt-and-stretch characteristics of dairy cheese—a feat unattainable with plant proteins.”
There is a structural point buried in that sentence. Conventional dairy has four caseins — alpha-s1, alpha-s2, beta and kappa — and the functional behaviour comes from how they assemble together, not from any one of them. A company producing a single fraction is not producing a substitute for casein; it is producing one component of one. Which fractions a company makes therefore constrains which applications it can serve — and that, in turn, shapes which route to market is even available to it. Fooditive claims all four. New Culture makes alpha-s1. Standing Ovation makes three.
Practical consequence: before evaluating a casein supplier, establish which fractions it actually produces. A single-fraction supplier and an all-four supplier are not interchangeable, whatever the datasheet says about protein content.
Four companies, four routes to market
| Company | Fractions claimed | Route to market | Manufacturing | US regulatory position |
|---|---|---|---|---|
| Fooditive | All four (alpha-s1, alpha-s2, beta, kappa) | Licensed to Leprino Foods — exclusive in cheese, non-exclusive elsewhere | Leprino for scale-up; CDMOs and third-party facilities for R&D and initial market testing | Self-affirmed GRAS Q4 2024; full FDA notification submitted 24 March 2025; no-questions letter described by the company as “anticipated” |
| New Culture | Alpha-s1 | Own brand, foodservice-first | Not disclosed in sources fetched | Self-affirmed GRAS (Feb 2024); no GRN number found; awaiting California label registration |
| Standing Ovation | Alpha-s1, alpha-s2, beta | B2B ingredient supply; no own factories | CMOs in Eastern Europe, one being commissioned in India, exclusive partnership with Ajinomoto in France, Tetra Pak on downstream | Targeting a no-questions letter by end of 2026; EFSA dossier described in March 2026 as about to be submitted |
| Those Vegan Cowboys | Not established in sources fetched | B2B supply to ~10 industry partners, plus the WildWestLand JV with Westland Kaas | Not disclosed in sources fetched | Joint GRAS notice with Formo, registered as GRN 1312, in active FDA review |
The spread is the story. Fooditive handed the cheese category — the single largest application, and the only one where casein’s functionality is irreplaceable — to an incumbent with existing plants and existing customers, and kept everything else open. Standing Ovation deliberately refused to build plants at all. AgFunderNews reports that the company is not raising money to build its own factories, and quotes Chardonnens on what it does instead: “We are working with CMOS [contract manufacturing organizations] in Eastern Europe. We are commissioning one in India, and we have an exclusive partnership with Ajinomoto here in France for large scale up.” New Culture went the other way and built a brand, with its first named partner a single high-end Los Angeles restaurant.
Practical consequence: if you are a manufacturer looking to formulate with animal-free casein in cheese specifically, Fooditive’s material now reaches you through Leprino or not at all. In every other category, it does not.
The gate none of them has cleared
Here is the finding that governs all four routes: as of every source we fetched, no precision-fermented casein has received an FDA “no questions” letter, and none has an EFSA novel food authorisation.
The whole category is trading on self-affirmed GRAS — a determination a company makes itself, on the advice of an expert panel it convenes itself, without the FDA having reviewed it. Green Queen reported in February 2024 that New Culture had “obtained what it claims is the world’s first self-affirmed GRAS (Generally Recognized as Safe) status for animal-free casein in the US”, and noted the contrast with the whey side of the category, where Perfect Day, Remilk and Imagindairy already held “no further questions” letters from the FDA.
One notice is in active review. FoodNavigator reported on 2 June 2026 that “Formo announced Monday that FDA issued the company’s GRAS notice (registered GRN 1312 in the public inventory), which is the final step before FDA decides whether to release a no-questions letter”, and described it as the only precision-fermented casein then in active scientific review in the US. That notice is filed jointly by Formo and Those Vegan Cowboys.
This is a sharp contrast with the whey and egg proteins we counted earlier, where twelve precision-fermented proteins have cleared the FDA with letters in hand. Casein has none. The difficulty Radman and Chardonnens describe in the laboratory has an exact analogue in the regulatory record.
It also sits on a moving foundation. Green Queen reported in July 2026 that the FDA has planned to eliminate the self-affirmed GRAS pathway, and that New Culture “currently has no updates on this front”. We have not read the FDA’s own proposal and cannot state its scope, status or timing — see What we could not establish. But any commercial plan whose US market access rests on self-affirmation rather than a letter is exposed to that change, and buyers should be asking about it now rather than later.
Practical consequence: ask a prospective casein supplier for its GRN number. “GRAS” and “self-affirmed GRAS” are different answers to that question, and only one of them survives a customer’s regulatory-affairs review.
The scale gap
There is a second gap, and it is arithmetic.
Leprino’s president Mike Durkin set out the ambition in July 2024: “Our intent is to produce animal-free casein in volumes that exceed hundreds of thousands of tons over the coming years. We will begin to scale up in the tens of thousands of tons in the coming year and expand as the market demand dictates at one of our US plant locations.”
That was a forward-looking statement made in mid-2024, and we found no later source confirming any production volume was reached against it.
Meanwhile Romain Chayot, co-founder of Standing Ovation, told Green Queen in March 2026: “Our current annual production is around one tonne of casein per year, and we anticipate rapid growth.”
These are different companies and the comparison is not like-for-like — one is an incumbent dairy processor’s stated ambition, the other is a startup’s disclosed current output. But they are the two published tonnage figures in this category, and they are five orders of magnitude apart. Anyone reading category-level capacity claims should know that this is the range those claims are being drawn from. It is the same problem we hit with signed offtake against available capacity: the demand-side numbers and the supply-side numbers are not on the same scale, and rarely on the same basis.
Notably, the one company that addressed pricing directly is not chasing parity. Chardonnens: “We are not in the game of one for one replacement. We are offering different functionality [to animal-sourced milk protein isolates] and enabling formulators to augment products with value added benefits.” He went on to say that price parity is not something the company is ready to play for right now, while adding that its roadmap towards cost parity was among the most important pillars of its new investors’ due diligence. We have paraphrased that second statement rather than quoting it, because the sentence as published contains a duplicated phrase and is not cleanly quotable.
That is a defensible position for a premium ingredient. It is also, unavoidably, a smaller market than the one the tonnage ambitions describe.
The counter-argument
The case for reading all this more optimistically is real.
Leprino taking exclusive cheese rights is exactly what a category needs at this stage. Precision fermentation’s chronic failure has been the gap between an ingredient that works and a manufacturer with the plants, the customers and the balance sheet to put it into products at volume. Handing cheese to the world’s largest mozzarella maker solves that in one move — and Fooditive kept every other application, so it has not sold the company for a single category.
On regulation: self-affirmed GRAS is a lawful pathway, used across the food industry for decades, and a company selling under it is not doing anything improper. GRN 1312 being in active review is the system working, not failing. And a “no questions” letter is not a prerequisite for revenue — it is a prerequisite for the kind of customer who will not buy without one.
The honest summary is that this category is roughly where precision-fermented whey was three or four years ago, with harder chemistry and better-capitalised partners. That is not a crisis. It is just much earlier than the deal announcements make it sound.
What we could not establish
- Any financial terms of the Leprino–Fooditive licence. No fee, royalty, upfront payment or minimum volume commitment appears in the joint press release or in AgFunderNews’s interview with Leprino’s president.
- Whether any volume has been produced under that licence against the “tens of thousands of tons” target stated for the year following July 2024.
- Any price or cost per kilogram for precision-fermented casein, from any of the five companies named here. We are recording this as a confirmed absence.
- The named US pizza chain reported to have contracted with New Culture. The only venue named in any source we fetched is Pizzeria Mozza, a single independent Los Angeles restaurant; Green Queen states the company keeps other names confidential. Treat “national pizza chain” claims about New Culture as unconfirmed.
- The scope, status and timing of the FDA’s proposed elimination of self-affirmed GRAS. We have this only as reported in secondary coverage and have not read the FDA’s own proposal. Anyone relying on it should go to the primary document.
- Which casein fractions Those Vegan Cowboys produces.
- Singapore SFA status for any of these companies’ casein — we found no source addressing it either way.
- A consistent public account of who holds self-affirmed GRAS. Green Queen stated in February 2024 that New Culture was the only precision-fermented casein producer allowed to sell in the US; in December 2025 it repeated that New Culture was the only one while the same article described Those Vegan Cowboys as holding a self-affirmed GRAS; by July 2026 it listed four companies. The most likely explanation is that the roster genuinely grew, but the December 2025 article contradicts itself and we are not going to silently resolve it.
What to watch
- Whether GRN 1312 draws a no-questions letter, and when. It is the first real test of whether the FDA will accept a precision-fermented casein safety case at all, and its outcome affects every company in the table, not just the two filers.
- Standing Ovation’s stated target of a no-questions letter by the end of 2026, and its EFSA submission. Both were stated in March 2026 with dates attached, which makes them checkable.
- Any disclosed production volume from Leprino. The gap between “hundreds of thousands of tons” and one tonne a year is the single most important unresolved quantity in this category, and only Leprino can close it.
- New Culture’s California label registration, which its own CSO described in July 2026 as having taken longer than expected. A domestic label approval holding up a product with self-affirmed GRAS is a useful reminder that federal clearance is not the only gate.