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FDA moves ahead with proposals to amend GRAS regulations
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**Green Queen & FoodDive & NutraIngredients**
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Recent regulatory updates: Mid-July 2025 → Mid-October 2025
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Cultivated meat regulation advances globally, with recent approvals expanding the category from human to pet food applications:
🇺🇸 Regulatory activity accelerates in the US, with several precision and biomass fermentation startups securing or advancing GRAS recognition for novel fats, proteins, and sweeteners:
| Startup / Company (HQ) | Date | Ingredient / Product approved | Technology | Country of approval | Type of approval / request | Comments |
|---|---|---|---|---|---|---|
| Geltor (USA) | October 2025 | Collagen | 🔬 Precision fermentation | USA | “no questions” letter | • It received a “no-questions” letter from the FDA, confirming GRAS status for its animal-free collagen, enabling its use in beauty-from-within, functional food, and supplement products. |
| • The ingredient is approved for use at levels ranging from 2% to 95%, depending on format and application. | ||||||
| • It says its infrastructure is ready for commercial scale. | ||||||
| Verley (France) | October 2025 | FermWhey ingredients (Native and MicroStab) | 🔬 Precision fermentation | USA | “no questions” letter | • It received a “no questions” letter from the FDA, confirming GRAS status for two of its functional ingredients, FermWhey Native and MicroStab. |
| Oobli (USA) | October 2025 | Brazzein-54 | 🔬 Precision fermentation | USA | “no questions” letter | • It received its third “no questions” letter from the FDA for brazzein-54, following brazzein-53 and monellin, confirming GRAS status as a sweetener for food and beverage applications. |
| Onego Bio (Finland) | September 2025 | Bioalbumen | 🔬 Precision fermentation | USA | “no questions” letter | • It received a “no questions” letter from the FDA confirming GRAS status for its Bioalbumen ingredient. |
| • Its egg white protein alternative can now be used in baked goods, beverages, sauces, and meat analogues. | ||||||
| • It is now sampling Bioalbumen and providing trial support to US food manufacturers, from craft bakeries to large-scale producers. | ||||||
| Amai Proteins (Israel) | September 2025 | Monellin | 🔬 Precision fermentation | USA | application for GRAS | • It submitted a GRAS notice to the US FDA for its monellin protein produced via precision fermentation. |
| Enifer (Finland) | September 2025 | PEKILO mycoprotein | 🍄 Biomass fermentation | USA | self-affirmed GRAS status | • It obtained self-affirmed GRAS status which enables collaborations with US food manufacturers for use in plant-based foods, sports nutrition, and healthy snacks |
| Nourish Ingredients (Australia) | August 2025 | Fat “Tastilux” | 🔬 Precision fermentation | USA | GRAS status from the Flavour and Extract Manufacturers Association (FEMA) | • It can now sell its fat to US food manufacturers, enabling meat-like flavour and aroma at low inclusion rates in plant-based, blended, and snack products. |
| Gourmey (France) | July 2025 | Duck cells | 🧫 Cellular agriculture | Europe | application for approval validated by both the Food Standards Agency (FSA) and Food Standards Scotland (FSS) | • It claims to be the world’s first cultivated meat company to reach this milestone in Great Britain. |
| Friends & Family Pet Food Company (USA) | July 2025 | Cultivated meat for dogs and cats | 🧫 Cellular agriculture | Singapore | regulatory approval to sell cultivated meat for dogs and cats | • It claimed it’s Asia’s first clearance, with inaugural treats containing 65–70% cultured cells. |
See regulatory updates of Q2 2025 here
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China emerges as global leader in cultivated meat patents and innovation support
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Comment: this table is quite impressive and confirms that there is a “black hole” about what’s happening around disruptive innovation in China beyond scientific publications. Chinese (and South Korean) universities and companies dominate this ranking even if we don’t hear about them very often. As food biotechnologies are getting prioritised by the Chinese government, we could expect an increase in funding towards companies applying the research coming out of these labs.
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Australia strengthens fermentation infrastructure with pilot-scale facility for precision-fermented ingredient production
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