It’s specified in Article 8 of the Administrative Measures for the Registration of Infant Formula Products that the applicant shall possess proper production capabilities compatible with the production of its products, comply with good manufacturing practices for powdered infant formula foods, and implement a Hazard Analysis and Critical Control Point (HACCP) system. When applying for infant formula milk powder registration, the applicant shall submit 9 required documents to the State Administration for Market Regulation (SAMR), including “8) Materials on R&D, production, and inspection capabilities”. Additionally, the review agency may organize on-site inspections as necessary for verification to ensure the consistency between the application materials and the actual circumstances.

It’s specified in Article 8 of the Administrative Measures for the Registration of Infant Formula Products that the applicant shall possess proper R&D capabilities aligned with its products. When applying for registration of infant formula milk powder products, the applicant shall submit 9 required documents to the State Administration for Market Regulation (SAMR), including 8) Materials on R&D, production, and inspection capabilities. Additionally, the review agency may organize on-site inspections as necessary for verification to ensure the consistency between the application materials and the actual circumstances.

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.