CIRS Assists Shandong Weiyan in Obtaining GRAS Status for Its Astaxanthin

Recently, Shandong Weiyan Biotechnology Co., Ltd. (“Shandong Weiyan”) achieved a milestone in its international compliance journey for its product, astaxanthin. With comprehensive professional support from CIRS Group, the company’s astaxanthin has been concluded by GRAS Panel as Generally Recognized as Safe (GRAS).

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.

Shandong Weiyan leverages synthetic biology to enable the green and efficient production of astaxanthin, a highly valued natural carotenoid that cannot be synthesized by the human body and must be obtained through the daily diet. The company developed its production strain using a chassis microorganism included on the European Union’s Qualified Presumption of Safety (QPS) list. Following the successful GRAS notice, the astaxanthin produced by Shandong Weiyan may be used in the United States as a food ingredient and is considered safe for use in food under the intended conditions of use and use levels, providing consumers with a source of astaxanthin.

About Shandong Weiyan Biotechnology Co., Ltd.

Shandong Weiyan Biotechnology Co., Ltd. was established in April 2014 at Binzhou. With superior surrounding environment and convenient transportation, the company has been recognized as a national high-tech enterprise and a “specialized and special new” small and medium-sized enterprise in Shandong Province. It has advanced green biological manufacturing technology and R & D platform. The project focuses on the green biological manufacturing of high-end animal health products, and produces high-end characteristic feed additives and veterinary drugs by biological fermentation, which has a broad market space. The company's products based on biological manufacturing technology have been gradually introduced to the market.

About CIRS Food Division

Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 food companies globally in achieving one-stop compliance solutions. CIRS offers a full range of regulatory services, including but not limited to China novel food applications, synthetic biology-derived foods, U.S. GRAS notices, EU novel food applications, health food registration, and food for special medical purposes (FSMP).

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