According to the information recently released by the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) products approved in China has reached 140. Companies must register FSMP products with the SAMR, and it is applicable to both foreign and domestic products sold in China. As of September 20, 46 new FSMP Products have been approved for use in 2023, covering 23 nutritionally complete foods, 18 nutritionally incomplete foods, and five infant formulas for special medical purposes.

On August 28, 2023, the State Administration for Market Regulation (SAMR) issued the Detailed Rules for Technical Evaluation of New Functions and Products of Health Food (Trial) (hereinafter referred to as the Detailed Rules), which takes effect on the day of publication. The Detailed Rules serve as the supplementary document of the Administrative Measures on Health Food Raw Materials Directory and Function Directory, providing more comprehensive requirements for the application of health food new functions and products. Enterprises can now refer to the Detailed Rules for a clear understanding of the application processes, dossier, and testing requirements. This marks a significant shift where health functions will no longer be confined to the current 24 functions outlined in the Directory of Health Functions Available to Be Claimed for Health Food – Non-nutrition Supplements (2023 Version), and a broader range of new health functions are expected to be included in the Directory of Health Food Functions.

The Technical Specifications for Testing and Evaluation of Health Food (2003 Version) was abolished in July 2018. After five years, on August 31, 2023, China’s State Administration for Market Regulation (SAMR) finally released the Directory of Health Functions Available to be Claimed by Health Food – Non-nutrition Supplements (2023 Version) and the supporting documents, including the long-awaited health food function evaluation methods.

On August 28, 2023, China National Center for Food Safety Risk Assessment (CFSA) issued 3 new food raw materials for public comment, namely (3R,3'S)-β,β-carotene-3,3'-Diol, Pichia kluyveri and Bacillus subtilis DE111. The deadline for public comment is September 28, 2023.

On August 18, 2023, we hosted a free webinar in Chinese and Japanese on the promotional barriers and key compliance points for functional food and food with medical properties. A lot of questions were raised during the webinar. We have collected questions and made a Q&A summary.

On August 23, 2023, the China National Center for Food Safety Risk Assessment (CFSA) published three new food additives for public comment, namely one new food nutrition enhancer and two food additives with an expanded scope. The deadline for public comments is September 18, 2023.

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on foods for special medical purposes (FSMP) applications to help you understand the current requirements in China.

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on health food and common food to help you better understand the current requirements in China.

China offers a wide range of food categories in addition to complex food regulations and standards. It is crucial to precisely determine whether the raw materials and additives used in a food product comply with Chinese regulatory standards before it is imported or launched on the market. How do you verify the compliance of food raw materials? What is the scope of use and amount of food additives permitted? Typically, these types of queries call for food enterprises to carry out multiple inquiries and research.

As of June 30th, the National Health Commission in China (NHC) issued two announcements (No.1 of 2023; No.3 of 2023), with a total of 42 products approved. Among them, 3 were new food raw materials (novel food), including, Leuconostoc mesenteroides subsp. Cremoris, Blueberry anthocyanins and Rye pollen.