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Infant Formula & FSMP
The highly anticipated industry event, the Growth Asia Summit, will once again commence in Singapore, aiming to provide a platform for exchange and sharing among R&D experts in the health food industry, market and trend analysts, top scholars, and well-known brands, offering comprehensive growth opportunities for the sector. The summit will focus on infant Nutrition, Food and Nutra for Kids, Maternal and Women’s Health; Active Lifestyle Nutrition and Protein Trends plus Healthier Product Innovation; Healthy Ageing etc.
The State Administration for Market Regulation (SAMR) of China has recently issued several new guidelines to simplify the registration process for three categories of foods for special medical purpose (FSMP), including: electrolyte formula, carbohydrate component formula, and protein component formula. These guidelines aim to facilitate FSMP registration and meet the nutritional needs of special populations.
On June 28, 2024, the 14th Session of the Standing Committee of the 14th National Peopl’s Congress approved a decision authorizing the State Council to temporarily adjust and trial provisions of the Food Safety Law of the People’s Republic of China in the Hainan Free Trade Port. This adjustment will be effective for a period of five years, starting from the date of this decision. The decision will come into effect on October 1, 2024.
According to the information from the Special Food Division of the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) approved in China has reached 192 by July 1, 2024. In the second quarter of 2024, 11 domestic FSMPs have been approved, including 3 nutritionally complete products, 6 nutritionally incomplete products, and 2 infant formula for special medical purposes.
Detailed information on 181 registered FSMP products
Recently, China's State Administration for Market Regulation (SAMR) held a national training session on the supervision of special food safety, reporting on the work carried out in 2023. In 2023, regulatory authorities strengthened the measures on prevention, management, inspection, and risk control, promoting high-quality development and ensuring high-level safety in the special food sector. The overall pass rate for special food inspections was 99.85%, an increase of 0.03% from the previous year, reflecting improved regulatory capabilities and consumer confidence.
Human milk oligosaccharides (HMOs) are the third most abundant solid component found in breast milk, playing a crucial role in establishing infant gut microbiota and immune functions. The discovery, production, and application of HMOs has been pivotal in promoting overall health, particularly in improving infant health and meeting nutritional needs.
In accordance with the Administrative Measures for Foods for Special Medical Purposes Registration (Announcement No. 85) issued by the State Administration for Market Regulation (SAMR), China's Center for Food Evaluation (CFE) reviewed the registration applications for FSMP seeking priority review and approval. The CFE is now making public the FSMP proposed for this procedure. The public notice period is five working days.
On May 15, 2024, in accordance with the Administrative Measures for Foods for Special Medical Purposes Registration (Announcement No. 85) issued by the State Administration for Market Regulation (SAMR), the Center for Food Evaluation (CFE) has reviewed the registration applications for FSMP seeking priority review and approval, and is now making public FSMP proposed for this procedure. The public notice period is 5 working days.
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.