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ZMUni Compliance Centre recently supported Shenzhen CynbioX Biotech in completing the Self-GRAS scientific safety evaluation for its AKG and Ca-AKG products under U.S. FDA GRAS guidelines, culminating in expert consensus. As one of the first domestically fermented AKG products to achieve GRAS compliance, this milestone establishes a strong regulatory foundation for entering the U.S. food market and sets a benchmark for process compliance evaluation in China, reinforcing pathways for international expansion in the nutrition and wellness sector.
Alpha-Ketoglutaric Acid (AKG) and its calcium salt form (Ca-AKG) are essential components of the tricarboxylic acid (TCA) cycle, critical for energy metabolism. Both are included in the U.S. list of old dietary ingredients, allowing lawful use as food ingredients. Unlike other domestic companies that rely on synthetic processes limited to flavoring applications, CynbioX employed a bio-fermentation method, enabling direct use as a food ingredient and demonstrating a distinct competitive advantage.
CynbioX® AKG is produced via whole-cell catalysis (patent ZL 201910787949.3) using food-grade Bacillus subtilis and a dual-enzyme expression system. This fermentation approach ensures product safety, reduces impurities, and improves purity. Both CynbioX® AKG and CynbioX® Ca-AKG are now produced at scale. Leveraging its parent company’s R&D capabilities, CynbioX has built an advanced synthetic biology platform and obtained multiple international certifications, including KOSHER, FSSC 22000, and HALAL. Preclinical studies in mice have validated AKG’s benefits in anti-aging, muscle growth, and exercise performance, with results published in peer-reviewed SCI journals, supporting further product innovation.
Founded in 2022, CynbioX is an innovative biotech company focused on synthetic biology. Its portfolio spans food ingredients, food additives, cosmetic ingredients, novel feed additives, and agricultural fertilizer additives, covering both raw materials and end-consumer products. The company emphasizes green manufacturing, rigorous process control, and international-quality standards, holding certifications such as FSSC 22000, HALAL, and KOSHER.
ZMUni Compliance Centre provides end-to-end global compliance solutions, helping cosmetics, food, and ingredient companies navigate regulatory requirements and enter international markets efficiently.
Our Food Division offers comprehensive, one-stop services, including ingredient entry (new food ingredients, food additives, and feed ingredients), product entry (compliance reviews for food products, health food registrations, and special medical food registrations), and import/export clearance. With over 10 years of experience, our team has successfully guided numerous businesses through market entry, specializing in novel foods, synthetic biology-based foods, U.S. GRAS certification, EU Novel Food applications, and health food registrations.
ZMUni Compliance Centre can help your business navigate global compliance and enter international markets efficiently. For inquiries, contact info@zmuni.com.
