China
Revised Standards for FSMP Infant Formula in China: Essential Compliance Deadlines and Registration Guidelines
China has introduced a new mandatory standard (GB 25596-2025) for infant FSMP, effective March 16, 2027, replacing the 2010 version. It requires re-registration of existing products and updates in ingredients, categories, and labeling to better address infants’ medical needs.
China has officially introduced a new mandatory national standard for foods for special medical purposes (FSMP) for infants—GB 25596-2025 Food Safety National Standard: General Rules for FSMP Infant Formula (the “new standard” or “new GB standard”). Set to take effect on March 16, 2027, this new standard will replace the current 2010 version (GB 25596-2010).
Under China’s strict FSMP regulatory system, products must be individually registered before entering the market. This means that during the upcoming two-year transition period, all FSMP infant formula products holding existing registrations must reapply for approval under the new standard to continue manufacturing and selling after the new rules take effect. The transition demands extensive efforts from businesses, including product R&D updates, production adjustments, compliance testing, regulatory filings, and packaging redesigns.
FSMP infant formula refers to specially formulated products designed to meet the unique nutritional needs of infants (0 to 12 months old) who experience feeding restrictions, digestive and absorption disorders, metabolic imbalances, or specific disease conditions. Given their medical importance, FSMP infant formula products are subject to stricter supervision than regular infant formula and other general food categories.
The new FSMP infant formula standard (GB 25596-2025) introduces important updates in ingredient requirements, product categories, and labeling rules, reflecting the latest scientific understanding of infant nutrition. Companies must carefully assess these changes to ensure timely compliance.
Previously, FSMP infant formulas were mainly categorized under formulations such as amino acid metabolism disorder formulas and formulas for preterm or low birthweight infants. The new standard expands the list to include six additional specialized categories:
This expansion allows for a broader range of clinically targeted nutritional products to better serve infants with specific medical needs.
| This article was first published by China Briefing , which is produced by Dezan Shira & Associates. The firm assists foreign investors throughout Asia from offices across the world, including in in China, Hong Kong, Vietnam, Singapore, and India . Readers may write to info@dezshira.com for more support. |
Read the rest of the original article.
