CIRS Assists Client in Gaining GRAS Notification for 2’-Fucosyllactose (2’-FL)!

Recently, CIRS supported Zhuhai Long Health Biotechnology (hereinafter “Long Health”) in achieving Self-GRAS notification for its 2’-Fucosyllactose (2’-FL), a key component of its human milk oligosaccharide (HMO) product line. It underscores Long Health's strong R&D capabilities and outstanding product quality and marks a significant advancement for the company in its expansion into the global nutrition and health market. Additionally, it serves as a powerful testament to CIRS's professional service capabilities.

Long Health secures self-GRAS notification for 2’-FL

About GRAS Notification

Generally Recognized As Safe (GRAS) is a critical regulatory pathway for food ingredient compliance in the United States. Only products that undergo rigorous evaluation and are unanimously recognized by a qualified panel of experts as meeting GRAS standards can earn this certification.

2’-FL is the most abundant oligosaccharide found in human milk. It plays a vital role in regulating infant gut microbiota, enhancing gut function, supporting immune health, and promoting brain development. It also offers health benefits for adults, such as improving gut health and boosting immunity. 2’-FL was the first HMO to be approved by the US FDA and the European Union as a food ingredient for applications in infant formula, dietary supplements, and foods for special medical purposes.

Long Health’s advanced production facility in Zhuhai

Long Health operates a state-of-the-art research and production facility with an annual capacity of 1,000 tons of HMOs.

The successful Self-GRAS notification permits its marketing and use as a safe food ingredient in the US This achievement boosts the company's global credibility and significantly supports its efforts to internationalize. Moving forward, Long Health will continue to enhance its research and development of HMOs and other bioactive compounds, delivering high-quality, safe functional food ingredients to clients worldwide and contributing to the improvement of human health.

About CIRS

The Food Division of CIRS Group was established in 2012. It boasts a specialized technical team for GRAS notification. The team has extensive experience in various fields, covering GRAS, new food ingredients, new food additives, food contact materials, synthetic biology foods, EU Novel Foods, dietary supplements, and special dietary foods.

CIRS operates a fully-owned subsidiary in the US. By leveraging the expertise of the CIRS USA and the international team, CIRS is able to provide enterprise various US food services, including but not limited to:

• US FDA GRAS Notification;
• US FDA Dietary Supplement Structure/Function Claim Notification;
• US New Dietary Ingredient (NDI) Notification
• US FDA Registration of Food Facilities; and
• US Food Label/Advertisement Information Review.

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