The FDA regulates GRAS ingredients in animal food through the GRAS Notification Program. Food companies and manufacturers may either submit a GRAS Notice (GRN) to the FDA to get a “No Questions” letter, or independently draw the GRAS conclusion based on the opinions of the panel group.

GRAS stands for Generally Recognized As Safe. It is the FDA primary framework for managing the safety of food ingredients. To obtain GRAS status, a company must compile a complete English‑language GRAS dossier and have it reviewed independently by a qualified panel of experts, who must reach a consensus on the ingredient’s safety. The dossier is a technical compilation that systematically explains the substance’s characteristics and its safety for consumption. Under 21 CFR Part 170 Subpart E, a GRAS notice must contain seven statutory parts.

On April 11, 2025, we hosted a free Chinese webinar on the key points and considerations in health food labels. Many questions were raised during the webinar.

As defined in the Regulation (EC) No 1333/2008, food additive shall mean any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods.

Recently, CIRS Group successfully assisted Penglai Marine in obtaining Self-GRAS Notice for its anhydrous magnesium citrate. It signifies that Penglai Marine’s anhydrous magnesium citrate may now be legally marketed and utilized as a safe food ingredient within the U.S. market, marking a significant step forward in Penglai Marine’s internationalization efforts.

On April 23, the State Administration for Market Regulation (SAMR) of China issued the Q&A on the Registration of Foods for Special Medical Purposes Infant Formula under the New National Standard (hereinafter referred to as the “Q&A”). The purpose of the Q&A is to facilitate the re-registration process following the promulgation of the National Food Safety Standard - General Rules for Food for Special Medical Purpose Infant Formula (GB 25596—2025) (hereinafter referred to as the “New National Standard”), guide enterprises in the standardized submission of applications, and ensure a smooth market transition.

Recently, China's National Health Commission (NHC) issued notifications regarding the approval and review of “Three new foods” (new food raw materials, new food additives, and new food-related products). The notifications included: Seven notifications of approval of review findings Thirty-nine notifications of extension notices; and Nine notifications of review opinions.

On March 27, 2025, Chinese NHC released 50 new national food safety standards, including GB 25596-2025: National Food Safety Standard – General Principles for FSMP Infant Formula. The transition period for this new standard, based on previous regulations and a comprehensive evaluation of various factors, has been set at two years. It will officially come into effect on March 16, 2027.

As defined in the Regulation (EC) No 1332/2008 on food enzymes, “food enzyme” means a product obtained from plants, animals or micro-organisms or products thereof including a product obtained by a fermentation process using micro-organisms “food enzyme preparation” means a formulation consisting of one or more food enzymes in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardisation, dilution or dissolution.

China NHC issued notifications regarding the acceptance of “three new foods”. The applications for 11 new food additives and 4 new food related materials have been received.