Frequently Asked Questions on Infant Formula Product Formulation in China

Recently, China’s Food Evaluation Center of the State Administration for Market Regulation released answers to frequently asked questions about infant formula product formulation. Details are as below:

Questions Related to Formulation and R&D

Q: What situations do not constitute significant differences between formulas from the same applicant for the same age group?

A: Significant differences refer to nutritional characteristics, not the variety of nutrients. The basis for product formulation and its differences should be the findings of breast milk research and nutritional research. The following situations do not constitute significant differences between formulas for the same applicant and age group:

(i) Different types and/or amounts of added dietary fiber, such as fructooligosaccharides (FOS), galactooligosaccharides (GOS), oligofructose, raffinose, polydextrose, yeast β-glucan, 2′-fucosyllactose (2′-FL), lacto-N-neotetraose (LNnT), etc.;

(ii) Different types and/or amounts of added nucleotides, such as 5'-cytidine monophosphate (5'-CMP), 5'-uridine monophosphate (5'-UMP), 5'-adenosine monophosphate (5'-AMP), disodium 5'-inosinate, disodium 5'-uridylate, disodium 5'-guanylate, disodium 5'-cytidylate, etc.;

(iii) Different types and/or amounts of added live bacteria, such as Bifidobacterium animalis subsp. lactis Bb-12, Bifidobacterium breve M-16V, Bifidobacterium longum subsp. BB536, etc.

Questions Related to Quality and Process

Q: What are the requirements for production capacity supporting documents for newly applying companies?

A: Production capacity supporting documents for newly applying companies should include the following:

(i) A list of essential production equipment (including equipment parameters) and facilities, ensuring that the equipment and facilities comply with relevant laws and regulations.

(ii) Environmental diagrams of the factory surroundings, floor plans of the production areas, and equipment layout diagrams.

(iii) Certificates or materials proving that the applicant complies with Good Manufacturing Practices (GMP) requirements for infant formula and operates the Hazard Analysis and Critical Control Point (HACCP) system.

Questions Related to Label and Instructions for Use

Q: Is a color label sample required for the application materials?

A: Both the original and a copy of the label sample in the application materials must be in color and clearly legible.

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