It’s specified in Article 8 of the Administrative Measures for the Registration of Infant Formula Products that the applicant shall possess proper inspection capabilities for producing its products, and conduct batch-by-batch inspections of manufactured products according to relevant laws, regulations, and national food safety standards for infant formula milk powder.

When applying for infant formula milk powder products registration, the applicant shall submit 9 required documents to the State Administration for Market Regulation (SAMR), including “8. Materials on R&D, production, and inspection capabilities”. Moreover, the review agency may organize on-site inspections as necessary for verification to ensure the consistency between the application materials and the actual circumstances.

CIRS Group provides a comprehensive analysis of the detailed requirements for preparing inspection capabilities-related materials for registration under the new national standard.

Companies with products already on the market

If the applicant is a manufacturer of products already on the market (i.e., a company whose product formulas have already been approved), only simplified documentation is required under Section 8 “Proof of Inspection Capability”. It falls into two specific types:

New applicants

For new applicants, the following materials shall be submitted:

1. Regarding self-inspection, basic information on inspection personnel, equipment and facilities, and full project qualifications shall be submitted. The list of inspection personnel should include details such as personnel, expertise, education/title, and work experience. Similarly, the list of main inspection equipment and facilities should include details such as equipment names, models, manufacturers, quantities, etc;
2. If self-inspection capabilities are not available, the name of the inspection agency responsible for batch-by-batch inspections, along with its legal qualifications and certification materials shall be submitted.

On-site inspection requirements

1. Inspection facilities, instruments, equipment, and personnel

• Equipped with proper inspection facilities, instruments, and equipment capable of meeting inspection needs;
• Calibrate and test the inspection facilities, instruments, and equipment in accordance with relevant provisions;
• Conduct capability validation for inspection items as required; and
• Ensure that inspection personnel meet the qualifications to fulfill inspection requirements.

2. Inspections

• The inspection standards and management systems for food raw materials, food additives, packaging materials, process products, and finished products are established and effectively implemented;
• A management system for inspection equipment is established and effectively implemented;
• Capable of conducting batch-by-batch full items factory inspections;
• Inspection reports and original records are well preserved as per regulations, allowing for the reproduction of the entire inspection process or traceability, and record-keeping is standardized; and
• Inspection certificate numbers can be traced back to inspection reports.

3. Labs

The labs are well-designed, with dedicated testing areas or rooms that meet the inspection conditions.

Further Information

1. 【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Base Powder
2. 【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Hydrolyzed Milk Protein
3. 【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China -Probiotics
4. 【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Research and Development Capacity
5. 【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Production Capacity

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