⚖️ Regulatory updates

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Recent regulatory updates: May → Mid-July 2026

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🇺🇸 In the US

One startup faced a US GRAS setback:

• The Protein Brewery (Netherlands) withdrew its US GRAS notice for its mycoprotein ingredient following FDA feedback on deficiencies in its submission, with resubmission planned and a “no questions” letter expected in Q1 2027.

Two startups achieved self-affirmed GRAS status in the US for caseins produced through precision fermentation, enabling sales to US food manufacturers:

• Formo (Germany) for its αS1-casein, while awaiting an FDA ‘no questions’ letter.
• Eden Brew (Australia) for its beta-casein.
  • The startup shifted its commercial focus from dairy products to health and supplements for nutrient delivery, food fortification (cheese, drinks) and clean-label applications.
  • It is scaling production with a co-manufacturer and is launching a $20M round to support commercial expansion, expected to close by year-end.

One company submitted a GRAS notice:

• Inner Mongolia Kingdomway Pharmaceutical (China) for its brazzein produced through precision fermentation.

🇪🇺 In Europe

• The Protein Brewery (Netherlands) received final EU approval for Fermotein, its mycoprotein produced through biomass fermentation, becoming the first novel mycelium ingredient authorised under the EU Novel Food Regulation.
  • Commercial launch in Europe is expected in Q3 2026, and the startup plans to supply 600 tonnes in 2027.

Comment: The Protein Brewery reached a major commercial milestone in Europe, but its US experience highlights that regulatory pathways remain heterogeneous and can require substantial additional evidence even after success in other jurisdictions.

🇸🇬 In Singapore

• Amai Proteins (Israel) obtained regulatory approval to sell Sweelin, its sweet protein produced through precision fermentation, in Singapore, becoming the first such ingredient authorised in the country.

See regulatory updates of Q1 + April 2026 here

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China’s food security strategy could reshape global protein markets

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• A new report published by Systemiq suggests China is turning food security into an industrial strategy centred on agricultural biotechnology, synthetic biology and alternative proteins.

• It highlights that China could apply to food and agriculture the industrial playbook previously used in EVs and solar panels, combining policy support, public funding and industrial scale-up (see picture below).

  

• It also projects a 25% drop in soybean imports by 2030 (23.5M tonnes), while alternative proteins could supply up to 55% of China’s animal protein demand by 2050, potentially reshaping global protein supply chains (see picture below).

  

Systemiq