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Infant Formula & FSMP
On April 3, 2024, in accordance with the Measures for the Registration of Food for Special Medical Purpose (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 the proposed FSMP for the priority process. The public notice period will be in effect for 5 working days.
According to the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) approved in China has reached 181. 17 FSMPs have been approved in the first quarter of 2024, including 16 domestic products and 1 imported. These include 3 domestic nutritionally complete products, 8 domestic nutritionally incomplete products, 5 domestic infant formula for special medical purposes, and 1 imported infant formula for special medical purposes.
Detailed information on 181 registered FSMP products
From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on foods for special medical purposes (FSMP) to help you gain a clearer understanding of the current requirements in China.
In our previous article (nutritionally complete food for ages 1-10 formula research and design recommendations Part 1), CIRS Group delves into the energy density, energy supply ratio of three macronutrients, and the impact of the raw materials sources on formula research. In this article, we further analyzed the vitamins, minerals, optional components and other nutritional components in 9 approved nutritionally complete foods for children aged 1-10.
We have made a list of free webinars scheduled for 2024 for your reference.
Adding probiotics in infant formula plays a positive role in nurturing healthy gut microbiota in infants. It not only helps build a robust community of beneficial bacteria but also effectively curbs the growth of harmful ones, steering the baby’s gut microbiota structure closer to the ideal state observed in breastfed infants.
On February 26, 2024, China National Center for Food Safety Risk Assessment (CFSA) issued 1 new food-related product for public comments. Comments are welcomed before March 25, 2024.
Hydrolyzed milk protein refers to a food ingredient obtained by hydrolyzing the milk protein in milk. Specifically, this involves breaking down whole proteins into smaller molecules—proteins, peptides, or amino acids—through heating and/or the action of substances such as acids and enzymes. This process reduces the allergenicity of the large protein molecules while maintaining a nutritional profile similar to that of the undecomposed proteins. Hydrolyzed milk protein can be divided into two types, namely hydrolyzed whey protein and hydrolyzed casein. Depending on the degree of hydrolysis, it can be further categorized into partially hydrolyzed whey protein, partially hydrolyzed casein, extensively hydrolyzed whey protein, and extensively hydrolyzed casein.
From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on foods for special medical purposes (FSMP) to help you gain a clearer understanding of the current requirements in China.