Regulatory frameworks for novel food ingredients are evolving on both sides of the Atlantic. In the US, the GRAS system is under review, with potential changes including the elimination of self-affirmed GRAS status and increased oversight from federal agencies. In parallel, Europe is beginning to clear paths for cultivated ingredients, initially through pet food, providing a glimpse of how regulatory acceptance may develop for cellular agriculture and other emerging technologies.
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Regulatory Shifts in the US: GRAS Under Review
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Regulatory Shifts in EU: Pet Food Leads for Cellular Agriculture
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Recent regulatory updates: December 2024 → April 2025
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| Startup (HQ) | Date | Ingredient / Product approved | Technology | Country of approval | Type of approval | Comments |
|---|---|---|---|---|---|---|
| MycoTechnology (USA) | April 2025 | Flavour modulator from a sweet protein derived of honey truffles | 🔬 Precision fermentation | USA | self-affirmed GRAS (FEMA) | |
| Vow (Australia) | April 2025 | cultured quail | 🧫 Cellular agriculture | Australia, New Zealand | ||
| Vivici (Netherlands) | March 2025 | beta-lactoglobulin | 🔬 Precision fermentation | USA | “no questions” letter | |
| Mission Barns (USA) | March 2025 | fat | 🧫 Cellular agriculture | USA | FDA pre-market consultation | if approved by the USDA, this would be the world’s first cultivated fat ingredient to enter the market. |
| February 2025 | duckweed (lemna), fresh aquatic plant | Europe | “novel food” | The advantages of duckweed are its high protein content (43%), its rapid growth, and its cultivation in greenhouses, vertical farms, or indoor urban, allowing large-scale production | ||
| Verley - formerly Bon Vivant (France) | January 2025 | beta-lactoglobulin | 🔬 Precision fermentation | USA | self-affirmed GRAS | It notified the FDA and expects a “no questions” letter by December 2025, aiming to launch products featuring its proteins in the US market by 2026.4o |
| All G (Australia) | December 2024 | lactoferrin | 🔬 Precision fermentation | USA | self-affirmed GRAS | This follows a news (end of November) where All G announced it gained regulatory approval for the same product (lactoferrin) in China, while also claiming its product had reached price parity (and even lower). |
| Oobli (USA) | December 2024 | monellin (sweet protein) | 🔬 Precision fermentation | USA | “no questions” letter | Already has approval for miraculin & brazzein |
| Nuritas (Ireland) | December 2024 | PeptiStrong, a muscle health ingredient | 🤖 Artificial Intelligence | USA | Letter of No Objection |
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The US Department of Defense Awards $60M in Biomanufacturing Grants
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