The Administrative Measures for the Registration of Infant Formula Products (hereinafter referred to as the Administrative Measures) was revised and issued on July 10, 2023, and came into effect on October 1, 2023. Following the implementation of the new national standards, the new registration regulations have further tightened the requirements for infant formula registration. How should enterprises make adjustments to cope with the new circumstances?

On December 1, 2023, the State Administration for Market Regulation (SAMR) released the revised Administrative Measures for Registration of Food for Special Medical Purposes (hereinafter referred to as the new regulations), consisting of 7 chapters and 64 articles, set to be implemented from January 1, 2024. CIRS Group has compared the new regulations with the current Administrative Measures for Registration of Food for Special Medical Purposes (hereinafter referred to as the current regulations) and summarized the following ten major changes for your understanding.

European Union (EU) has maintained a relatively stable trend of food substance approvals in Q2 over recent years, while the approval of food substances in Q1 and Q4 experience notable fluctuations. In contrast, Q3 has seen only one approval in 2021 and 2022, and none this year. While Q4 just started, it has seen two newly approved HMO substances, 3-FL and 6'-SL, both of which are of microbial origin.

Human Milk Oligosaccharides (HMOs) stand as a vital category of naturally occurring nutrients found in breast milk. Currently, there are over 200 known structures of HMOs, with 6 types being extensively researched, of which the nutritional necessity and safety have gained broad international recognition. Notably, in China, there’s widespread attention on four compliant HMOs: 2’-fucosyllactose (2’-FL), lacto-N-neotetraose (LNnT), 6’-sialyllactose sodium salt (6’-SL), and 3’-sialyllactose sodium salt (3’-SL).

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 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.

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.

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.

According to the recent consulting situation from CIRS, we found that enterprises have asked more valuable questions related to FSMP, indicating that they are gradually comprehensive on this kind of products. In order to help consumers and enterprises to have a better understanding of FSMP registration-related affairs and its clinical trial requirements, CIRS Group will hold a webinar in June 14.

From 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.