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Recent regulatory updates: April 2025 → Mid-July 2025
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| Startup / Company (HQ) | Date | Ingredient / Product approved | Technology | Country of approval | Type of approval / request | Comments |
|---|---|---|---|---|---|---|
| Wildtype (USA) | June 2025 | cultivated salmon | 🧫 Cellular agriculture | USA | “no questions” letter | • It received a “no questions” letter from the US Food and Drug Administration (FDA), authorising the sale of its cultivated salmon and making it the first lab-grown fish to complete the FDA’s pre-market safety consultation. |
| • The product combines cultivated Pacific salmon cells with plant-based ingredients to replicate conventional taste, texture, and appearance. | ||||||
| • Its sushi-grade salmon is already available in US restaurants, with plans to scale within foodservice before moving into retail. | ||||||
| Vow (Australia) | June 2025 | Japanese quail | 🧫 Cellular agriculture | Australia + New Zealand | final regulatory approval | This final regulatory approval enables official market entry into Australian restaurants. |
| Infinite Roots (Germany) | June 2025 | mycelial biomass | 🍄 Biomass fermentation | USA | review of GRAS Notice | The FDA is reviewing a GRAS Notice from Infinite Roots for mycelial biomass, intended for use at up to 25% in meat, dairy and cheese analogues, seafood, and baked goods. |
| MyForest Foods Co.: Ecovative spinout (USA) | May 2025 | mycelium from oyster mushroom | 🍄 Solid-state fermentation | Europe | public consultation for novel food authorisation in the EU | The European Food Safety Authority (EFSA) opened a public consultation on MyForest Foods Co.’s application to allow mycelium from oyster mushroom, made by solid-state fermentation, to be sold as a novel food in the EU, inviting scientific feedback before any approval. |
| TurtleTree (Singapore) | May 2025 | lactoferrin | 🔬 Precision fermentation | USA | “no questions” letter | • It confirms its Generally Recognised as Safe (GRAS) status for use in functional foods, beverages, and supplements. |
| • The startup wants to enter the EU and Singapore markets, leveraging FDA clearance to ease regulatory approvals. | ||||||
| • It aims to incorporate LF+ into infant nutrition within the next two to three years. | ||||||
| • It also says LF+ could undercut bovine lactoferrin (currently $700–$800/kg) by 2029, with plans to halve today’s production costs. | ||||||
| Comment: this is the first Full Gras approval for lactoferrin in the US. It was also the first to be declared self GRAS in late 2023. Beyond TurtleTree, All G (from Australia) is also self-GRAS in the US (and seeking for a “no questions” letter. | ||||||
| KÄÄPÄ Biotech (Finland) | May 2025 | mushroom extract powders produced by patented NordRelease process | 🔊 Ultrasonic Assisted Extraction | Europe | classified as non-novel in the EU | • It received EFSA approval for its patented NordRelease process, making it the only non-water-based extraction method for mushroom powders cleared as non-novel in the EU. |
| • It is also raising an equity round, expected to close within three months. | ||||||
| SimpliiGood (Israel) | April 2025 | texturised fresh spirulina, branded as Simplii Texture | 🍔 Plant-based | Europe | classified as non-novel ingredient suitable for food applications | • The launch of its full-scale manufacturing line allows the startup to ramp up production of its texturised spirulina to hundreds of tonnes per year, supporting the commercial rollout of its smoked salmon analogue. |
| • It says each kilogram of Simplii Texture can be used to create 3-4 kg of its plant-based, clean-label smoked salmon alternative. | ||||||
| FERM FOOD (Denmark) | April 2025 | rapeseed cake | 🍔 Plant-based | |||
| ♻️ Upcycling | Europe | authorised to market as a food ingredient | • This sidestream of rapeseed oil contains 28-30% protein and could be used in a variety of foods, including bread, cakes, and plant-based products. | |||
| • The startup says it could be available on a large scale and at reasonable price. | ||||||
| Bestzyme (China) | April 2025 | Mellia Brazzein | 🔬 Precision fermentation | USA | “no questions” letter | • Bestzyme is a subsidiary of GenScript. |
| • Its brazzein have industrial-scale application across confectionery, including chocolate. | ||||||
| CellX (China) | April 2025 | morel mycelium ingredient | 🍄 Biomass fermentation | USA | self-affirmed GRAS | • Starting with cellular agriculture startup it is now focusing on biomass fermentation. |
| • It introduced what it claims to be the world's first morel mushroom mycelium jerky, under its new consumer brand, Mourish. | ||||||
| • Its morel mycelium ingredient is self-affirmed Generally Recognised as Safe (GRAS) in the US. | ||||||
| • It relocated its headquarters to the US and plans to scale up production from 12,000 to 30,000-litre fermenters by partnering with co-manufacturers, while exploring B2B supply chain opportunities. |
See regulatory updates of Q1 2025 here
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Seven US states ban cultivated meat
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Moolec secures US patent for porcine heme-producing soybean
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FAO calls for global regulatory clarity on precision fermentation
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Comment: the table in the PDF showing the differences between the countries in terms of regulation (or simply knowing if they have yet defined what precision fermentation is) is quite interesting and unique.
**FoodSafety magazine (full report in PDF below)**
FAO Report on Food Safety Aspects of Precision Fermentation.pdf
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US ramps up biotech and alt-protein leadership with MABA, Biotech Caucus, and California committee
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