【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China -Probiotics

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.

So, what are the requirements for registering infant formula adding probiotics? To give businesses a clear picture, CIRS Group provides detailed analyses in conjunction with relevant infant formula regulations and Q&A guidelines.

1. What are the requirements for strains that can be used in infant formula milk powder?

The viable count of active bacteria in infant formula products containing strains should be ≥ 106 CFU/g (mL). In addition, the strains (strain number) should comply with the list of strains permitted for use in infants and young children food published by the former Ministry of Health (MOH) and the National Health and Family Planning Commission (NHFPC), and the National Health Commission (NHC), as shown in Table 1.

Table 1 List of strains that can be used in infants and young children's food

*Restricted for use in food for children aged 1 and above.

2. What are the testing requirements for active bacteria during the research and development process?

1) Uniformity process validation

The sample uniformity analysis indicators should at least include macro-nutrients, vitamins, and minerals from essential components. Optional components and other difficult-to-mix ingredients may also be considered. For each category of indicators, smaller amounts of ingredients that are difficult to mix, such as active bacteria or lactoferrin, should be selected.

2) Product stability study

According to the Guidelines for Stability Studies of Infant Formula Products (Trial), it’s crucial to prioritize test items that are prone to change during the shelf life and may impact their quality, safety, and nutritional adequacy. These key test items should include at least those listed in the appendix (see Table 2).

Given that active bacteria are typically present in small quantities in the formula, stability analysis indicators for infant formula products should encompass active strains. For certain strains that are unsuitable for accelerated testing conditions, historical long-term data from formulas with similar moisture content can be adopted. Essentially, if the active bacteria added to the formulation remain consistent before and after adjustments according to the new national standard, and there’s no significant difference in moisture content, historical long-term data from formulas previously registered by the same applicant can be leveraged for analysis.

Table 2 Key stability test items

3. What key points should be noted before registration?

1) Types of registration under the new national standard

For products that have already obtained registration and where the formula is to be modified by adding or removing optional ingredients, the applicant should cancel the original formula and apply for a new one. Specifically, when it comes to dietary fiber (including fructooligosaccharides, galacto-oligosaccharides, polyfructan, raffinose, polydextrose, beta-(1,3)-D-Glucan, etc.), L-DIHYDROOROTIC ACID, and strains that can be used in infants and young children food, a new formula should only be applied when a specific category of ingredient is added or removed (excluding changes within the same category of ingredients).

2) Formula distinctiveness

Distinctiveness refers to differences in nutritional characteristics rather than the variety of nutritional components. The basis for product formulas and their distinctiveness should be grounded in research on breast milk and nutritional science findings. When the same applicant adds different strains and/or quantities of probiotics within formulas for the same age group, this does not constitute a significant difference. It can be understood that a clear difference between two formulas only exists when one formula includes the addition of probiotics as an ingredient, while the other does not.

4. What materials are required for registration under the new national standard?

1) A statement on the source of raw materials of the strain;

2) A strain identification report that meets the following requirements:

• The report can be either provided by the applicant or the supplier;
• The report shall be accurate to the strain level; and
• The identification process shall be completed within 2 years prior to the date of application.

3) Preventive and control measures for potential contamination of the product by other bacteria due to the use of the strain, including at least the following:

• Quality specifications and test reports for active bacteria raw materials: Provide quality specifications, hygiene indicators, and relevant test reports, including but not limited to strain composition, counts, as well as chemical and microbiological contamination indicators, among others;
• Raw materials management: There are explicit requirements for the selection of suppliers, inspection procedures (including but not limited to various quality specifications and hygiene indicators), raw material storage and transportation conditions, and warehouse management for both incoming and outgoing goods;
• Process control concerning finished products production: Ensure consistency of strains used during the process, and provide key processes using the raw material, and control measures for cleaning procedures, among others; and
• Measures for testing relevant items in finished products: Conduct batch-by-batch testing for active bacteria units and microbial contamination indicators in the finished products. If anaerobic active bacteria, such as bifidobacteria, are used, the product inspection report should include the total colony count item.

4) Simplified application materials

For the same applicant applying for different formulas with identical strains, raw material compositions, and suppliers, relevant documentation such as strain traceability and contamination control can be streamlined. Simply speaking, complete details can be provided for one formula, while consistency statements are adequate for the rest.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further information

Strategies for Enterprises in Response to New Infant Formula Registration Regulations in China

【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Base Powder

【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Hydrolyzed Milk Protein

【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Research and Development Capacity

【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Production Capacity