On March 27, 2025, the National Health Commission and the State Administration for Market Regulation jointly issued Announcement No. 2 of 2025, officially releasing 50 national food safety standards and 9 standard amendment documents. This comprehensive revision covers a wide range of areas, including:
- Food labeling and nutritional labeling specifications
- Infant and special dietary foods
- Various food additives and nutritional fortifiers
- Food contact materials
- Microbiological and pollutant limits
- Physical and chemical testing and risk assessment methods
Key Focus: GB 25596-2025 General Principles for Special Medical Purpose Infant Formula
This standard revision aims to achieve coordination and unification among ordinary infant formula, adult special medical foods, and general food safety standards. The primary objectives are to scientifically manage product risks and provide clearer normative guidelines for enterprise formula research and product innovation.
Core Changes in Detail
1. Product Form Restrictions Removed to Encourage Innovation
The previous limitations on product "powder or liquid" forms have been deleted, opening up new possibilities for product development and design.
2. Six New Specialized Product Categories Precisely Covering Clinical Needs
Six new specialized product categories have been added:
- Ketogenic formula
- Anti-reflux formula
- Lipid metabolism disorder formula
- High-energy formula
- Protein component formula
- Medium-chain fatty acid component formula
3. More Scientific Ash Content Indicators with Broader Usage Scenarios
The new standards now require breast milk nutritional supplements and liquid products mixed with breast milk to comply with ash content limits, ensuring a more comprehensive approach to product assessment.
4. Unified pollutant and microbiological limits referencing universal standards
Instead of establishing separate limit indicators, the new standards now uniformly reference:
- GB 2762-2022 Limits of Pollutants in Food
- GB 29921-2021 Microbiological Limit Standards
- Other general standards
Implications for the Industry
This revision represents a significant step towards:
- Encouraging product innovation
- Enhancing clinical precision
- Standardizing safety assessments
- Providing clear guidelines for research and development
Enterprises in the infant formula and special medical purpose food sectors should carefully review these new standards to ensure compliance and explore new product opportunities.