On June 15, 2021, the State Administration for Market Regulation (SAMR) has compiled and formed the "Questions and Answers on the Registration of Infant Formula Milk Powder Product Formula", which is hereby released. Today is the second part.

10. What circumstances do not belong to the same applicant and there are obvious differences between the formulas of the same age group?

Answer: Obvious differences refer to nutritional characteristics rather than nutritional ingredients. The basis of product formulas and their differences should be the results of breast milk research and nutrition research. The following situations do not belong to the same applicant and there are obvious differences between the formulas of the same age group:

(1) Add different types and/or amounts of dietary fiber, such as fructooligosaccharides, galacto-oligosaccharides, polyfructose, raffinose, polydextrose, yeast β-glucan, etc.;

(2) Add different types and/or amounts of nucleotides, such as 5'-CMP, 5'-UMP, 5'-AMP, 5'-inosinic acid disodium, 5'-uridine acid disodium, 5'-guanylic acid disodium, 5'-cytidine acid disodium, etc.;

(3) Add different types and/or amounts of active bacteria, such as Bifidobacterium animalis, Bifidobacterium lactis, Lactobacillus rhamnosus, Reuteri, Lactobacillus fermentum, Bifidobacterium breve and Lactobacillus acidophilus Wait.

11. What are the relevant materials including strain traceability and the prevention and control of bacterial contamination?

Answer: Strain traceability, bacteria contamination prevention and control and other related materials, include the source description of the raw material of the strain, the identification report of the strain, and the prevention and control measures that may cause product contamination due to the use of strains (such as quality specifications and test reports of active bacteria raw materials, activity bacterial raw material management, processing control of final product, detection and other measures of related items in final product).

12. What materials are included in the production process description?

Answer: The production process description includes the following materials:

(1) The registration certificate containing the reason and rationality of the process change.

(2) A description of the similarities and differences between the production processes (including production procedures, process parameters, key control points, main production equipment, work area division, raw and auxiliary materials input links, etc.) between different recipes of the same series, and the main differences are marked in a list.

(3) Complete production process flow chart and its text. The production process flow chart should be clearly written, indicating the main production processes, key control points and their process parameters, as well as the division of work areas. The production process text includes the production process text description, related production equipment (name, model), control parameters and control measures of critical control point.

13. What are the main production processes?

Answer: The main production processes of wet process generally include clean milk and pasteurization (using raw milk), ingredients, homogenization, sterilization, concentration, spray drying and cooling, product packaging; dry process generally includes preparation and feeding, metering ingredients, pre-mixing, dry mixing, product packaging; the dry-wet composite process includes all the main production processes of the above-mentioned wet process and dry process.

14. What are the contents of the production process text description, related production equipment (name, model), control parameters and control measures of critical control point?

Answer: The production process text description refers to the text description corresponding to the production process flow chart, including the description of each process, process parameters, and the input link, input sequence, and input method of each raw and auxiliary material marked in the flow chart.

Related production equipment is provided in the form of a list of main production equipment, including equipment name and model. Wet process equipment includes: pasteurization equipment (using raw milk), batching equipment, homogenization equipment, sterilization equipment, concentration equipment, spray drying equipment, packaging equipment; dry process equipment includes: tunnel sterilization equipment, metering and batching equipment, pre-mixing equipment, mixing equipment, product packaging equipment; dry-wet composite process equipment includes the above-mentioned wet production and dry production equipment.

Control parameters and control measures of critical control point can be determined according to the actual needs of the enterprise, including the scientific and reasonable explanation of the critical control point settings, and the detailed description of the control parameters and control measures.