CIRS Supports Enhe Aiju’s ZeaVida® Zeaxanthin Obtain FDA GRAS Notice

Recently, Enhe Aiju (Hangzhou) Science and Technology Co., Ltd. (Enhe Aiju) has completed the FDA GRAS notice for its self-developed zeaxanthin, produced via fermentation using production strain Yarrowia lipolytica CGMCC 39021 (GRN No. 1300). This is the world’s first high-concentration crystalline zeaxanthin product manufactured at commercial scale using cell factory technology to receive GRAS, fully under the support of CIRS Group.

FDA GRAS is the authoritative notification of food ingredient safety by the US FDA and is one of the most important safety reference standards in the global food ingredient industry. Enhe Aiju conducted several rigorous assessments around product safety, including acute toxicity tests, teratogenicity tests, 90-day oral toxicity tests, and full-component studies.

Zeaxanthin is recognized as a core active ingredient for eye health. However, its industrial supply has long been heavily dependent on marigold cultivation, which is constrained by land, climate, and seasonal factors, making stable, scalable production challenging. By replacing agricultural extraction with precision fermentation, Enhe Aiju has achieved a milestone. For the first time, a functional raw material that was entirely reliant on agricultural cultivation has been recognized by the world’s strictest food safety regulatory systems in an industrial fermentation form.

From marigolds to fermentation tanks: Breaking the structural constraints of traditional supply chains

The zeaxanthin content in dried marigold flowers is only about 0.015% to 0.05%, requiring large-scale cultivation to meet industrial extraction demands. Production is strictly limited by geography, climate, and season, leading to significant capacity fluctuations. Prices vary with the harvest season, and supply stability has long been a pain point in the industry.

Enhe Aiju is committed to creating a new paradigm in biomanufacturing and production by integrating artificial intelligence, synthetic biology, and end-to-end industrial capabilities, advancing AI4S to the next stage. Leveraging its self-developed SAION AI-assisted synthetic biology precision fermentation technology, Enhe Aiju has built an efficient yeast cell factory, overcoming production bottlenecks caused by insufficient rate-limiting enzyme activity. The company has also solved three major technical challenges: cell toxicity at high concentrations of hydrophobic carotenoids (strain tolerance), product purity, and production efficiency. Within two years, Enhe Aiju achieved full-scale integration from laboratory to industrial production, breaking free from seasonal constraints and ensuring stable year-round output.

Product advantages and efficacy validation of ZeaVida®

ZeaVida® achieves higher consistency in optical purity by precisely controlling fermentation conditions, with a full-scale data-driven system monitoring and tracking all critical control points to ensure batch-to-batch uniformity. Compared with plant-extracted products, the fermentation-based approach replaces dependence on agricultural raw materials with controlled parameters, effectively reducing safety uncertainties from pesticide residues, heavy metals, and geographic variability. This not only ensures a stable supply but also significantly lowers costs.

In terms of efficacy, ZeaVida® has been validated for blue light protection and antioxidant effects through zebrafish models and has completed clinical studies in rats. Under the same dosage conditions, results indicate that precision fermentation-derived zeaxanthin exhibited bioavailability comparable to that of commercially available marigold-derived zeaxanthin.

ZeaVida® has been notified by the FDA as GRAS, laying a compliance foundation for the product to enter the global market, and further validating the feasibility of precise fermentation moving towards international commercial applications. As product technologies continue to mature, biomanufacturing capabilities are accelerating their integration into global supply chains through increasingly sophisticated and scalable product formats.

About Enhe Aiju

Enhe Aiju is a global Physical AI-driven biomanufacturing company on a mission to make biotechnology a reliable and scalable industrial production engine. By combining artificial intelligence, synthetic biology, and industrial-scale execution, the company is redefining how biological products are discovered, developed, and manufactured. At the core of its platform is a world-class Physical AI-powered biofoundry that seamlessly integrates strain engineering, process optimization, and commercial-scale production. This enables the company to transform biological innovation into scalable solutions for food, nutrition, personal care, and other consumer and industrial applications. Together with partners around the world, Enhe Aiju is advancing sustainable biomanufacturing through greener, more efficient, and commercially viable biological solutions, helping accelerate the transition to a more sustainable global economy.

About CIRS 

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% hold Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.