In 2023, 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) were officially approved as new food nutrition enhancers in China, marking a regulatory milestone regarding human milk oligosaccharides (HMOs), a globally recognized category of essential nutrients. Since then, several other HMOs continue to progress along the compliance pathway: on May 10, 2024, the Center for Food Safety Assessment (CFSA) issued the draft and reopened the period for public consultation for 2’-FL and LNnT.

To standardize the clinical trial process of foods for special medical purposes (FSMP), the State Administration for Market Regulation (SAMR) recently revised and issued the Quality Management Specifications for Clinical Trials of Foods for Special Medical Purposes (the Specification), which aims to ensure the scientific integrity, authenticity, and reliability of data and results, while safeguarding the safety and rights of trial subjects and consumers.

Frequently Asked Questions on FDA Generally Recognized As Safe (GRAS) Certification, Vol. 2

On May 9, 2024, China National Center for Food Safety Risk Assessment (CFSA) issued 7 new food-related products for public comments, including 1 new food contact coating, 4 new food contact additives with expanded scope, 1 new food contact resin, and 1 food contact resin with expanded scope.

On May 10, 2024, China National Center for Food Safety Risk Assessment (CFSA) issued 4 new food additives for public comments, including 1 new food enzyme, 2 new food nutrition enhancers, and 1 food nutrition enhancer with expanded scope.

From April 28 to May 5, 2024, the National Health Commission (NHC) Government Services Platform issued notifications regarding the acceptance of “three new foods” (new food raw materials, new food additives, and new food-related products). The applications for Lemon Myrtle and fructo-oligosaccharide have been accepted.

In order to standardize the procedure for the priority review and approval of registration of food for special medical purpose (FSMP), in accordance with the Administrative Measures for the Registration of Foods for Special Medical Purpose, the State Administration for Market Regulation (SAMR) has drafted the Procedures for Priority Review and Approval of Registration of Foods For Special Medical Purpose for public feedback. Comments are welcomed before May 30, 2024.

Recently, the State Administration for Market Regulation (SAMR) issued the Announcement on Simplifying Consular Authentication Materials for Registration and Filing of Imported Health Foods (hereinafter referred to as the “Announcement”).

To thoroughly implement the current Food Safety Law of the People’s Republic of China, the Administrative Measures on Food Business Licensing and Filing, and to address common concerns regarding food business safety, the State Administration for Market Regulation (SAMR) has recently revised and issued the General Rules for Food Business Licensing Review (hereinafter referred to as the “General Rules”), which will take into effect from the date of issuance.

On April 30, 2024, the State Administration for Market Regulation (SAMR) issued Technical Requirements for Filing of Health Food Raw Materials Ginseng radix et rhizoma, Panacis quinquefolii radix, and Ganoderma (hereinafter referred to as the “Technical Requirements”), implementing a filing management system for health food products using these three ingredients as raw materials.