CIRS Assists Runhan in Obtaining GRAS Status for Its GlcNac

Earlier in September 2025, Shandong Runhan Biotechnology Co., Ltd. (“Runhan”) achieved a milestone in its international compliance journey for its core product, GlcNac. With comprehensive professional support from CIRS Group and its U.S. subsidiary, the company’s GlcNac has been concluded by GRAS Panel as Generally Recognized as Safe (GRAS).

01 GRAS Notice

GRAS is the abbreviation for “Generally Recognized as Safe.” It refers to a safety evaluation system for food ingredients and additives established by the FDA in accordance with the CFR. A substance that has obtained GRAS status means its safety has been widely recognized by the scientific community and regulatory authorities, allowing it to be legally used as a food ingredient or dietary supplement component in the U.S. market. GRAS notice carries a high level of international credibility and serves as an important gateway for companies seeking to expand their food ingredients or additives into global markets.

The GlcNac developed by Runhan has successfully passed rigorous scientific review and meets GRAS safety standards, supported by advanced microbial fermentation technology, comprehensive toxicological safety evaluations, and long-term historical consumption data. This achievement signifies that the technological capabilities and product quality of Chinese biomanufacturing enterprises have gained recognition in high-standard international markets. The production strain used for this product is engineered from a chassis microorganism listed under the EU Qualified Presumption of Safety (QPS) framework, ensuring from the source that there is no risk of endotoxin production and significantly enhancing the biological safety of the product.

02 Ingredient Overview

GlcNAc (chemical formula C₈H₁₅NO₆), is the fundamental structural unit of chitin found in the exoskeletons of crustaceans. It also naturally occurs in various biological tissues, such as animal cartilage and fungal cell walls. Traditionally, GlcNAc has been produced through chemical or enzymatic hydrolysis of shrimp and crab shells. However, these methods present issues such as environmental pollution, strong dependence on raw materials, and potential allergen risks. The microbial fermentation process adopted by Runhan is allergen-free, highly efficient, and environmentally friendly, representing technological advancement in the food industry.

As a naturally occurring dietary component, humans have long ingested GlcNAc through everyday foods. In Europe and North America, GlcNAc and its derivatives have been widely used in dietary supplements for many years, accumulating extensive safety data.

GlcNAc plays important physiological roles in the human body. It is a key precursor for the synthesis of glycosaminoglycans and proteoglycans, which are essential components of joint cartilage matrix, synovial fluid, skin, and mucosal tissues. Based on its biochemical properties, GlcNAc demonstrates broad application value and significant growth potential across multiple sectors, including functional foods, dietary supplements, FSMPs, and personal care products.

03 Company Profile

Shandong Runhan Biotechnology Co., Ltd.

Shandong Runhan Biotechnology Co., Ltd. is a high-tech enterprise specializing in the research, production, and technical services of bioproducts. The company is committed to providing high-quality functional ingredients and innovative solutions for industries such as personal care and life & health. With a core focus on the R&D and production of bio-fermented products such as GlcNAc, the company’s product portfolio is widely applied in life and health sciences, moisturizing skincare, animal nutrition, and plant nutrition sectors.

About CIRS Group

Headquartered in Hangzhou, CIRS Group operates 11 subsidiaries across the United States, Europe, South Korea, and Japan. With a specialized global novel ingredient registration team, it provides comprehensive global submission services for novel food ingredients in China, GRAS notice in the U.S., Novel Food approvals in the EU, and novel feed additives in China, Europe, and the U.S. It boasts extensive experience and numerous successful cases, including D-allulose, HMOs, steviol glycosides, NMN, Glucosamine Hydrochloride, NAG, and other substances produced using synthetic biology technologies, as well as various alternative proteins, PQQ, Wheat Polar Lipids, Jatropha Curcas, AKK, Probiotics, and more. 

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