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Q&A about Infant Formula Registration from CFE

from CIRS by


On July 15, 2019, the Center for Food Evaluation answered the frequently asked questions about infant formula milk powder and its registration. The details are as follows:

1. What quality and safety standards shall be provided for the product raw materials and excipients without national standards?

The applicant shall provide the applicant's enterprise standards, supplier's enterprise standards or product quality specifications:

(1) The quality standards or specifications of food additives shall refer to one of the internationally recognized standards: CAC, ISO, FCC, Japan's Specifications and Standards for Food Additives, and European Union food additive quality standards. Apart from the above standards, USP, JP, EP and Chinese pharmacopoeia are also available for nutrition enhancers.

(2) The quality standards or specifications of food raw materials and excipients shall conform to GB 2761, GB 2762, GB 2763 and other relevant food safety national standards.

2. What are the requirements for the marking of production process flow chart?

The production process flow chart shall be clearly written, indicating the main production process, process parameters, key control points and zoning conditions.

3. Does the product using base powder need to carry out commercial production process verification for different batches of base powder?

(1) The formula using base powder should use three batches of base powder for commercial production process verification.

(2) Wet and dry composite process shall verify the complete process of three batches from the feeding of wet process to the end of finished product packaging.

4. What are the requirements on sample homogeneity analysis index in process verification?

(1) Sample homogeneity analysis should include at least macro components, minerals, vitamins, selective components and other components that are not easily mixed.

(2) Homogeneity analysis of dry mixing samples with base powder should also be carried out for the detection and analysis of the corresponding indicators of all the mixing components.

5. What are the requirements on process stability analysis in process verification for newly applied enterprises?

For newly applied enterprises, the stability analysis of key process parameters should be present in the process stability analysis. For example, multi-batch determination of key parameters should be carried out to determine whether the processing parameters are within the required range, so as to determine the stability of the process.

6. What are the requirements on the production capacity proof materials for newly applied enterprises?

(1) Submit the list of production equipment and facilities (including the parameters), and the equipment and facilities shall comply with relevant laws and regulations.

(2) Submit the drawing of the surrounding environment of the factory, production site plan and equipment layout drawing.

(3) Submit the applicant's certificates or materials proving that the applicants implement the good manufacturing practice as well as hazard analysis and critical control point system.

7. What are the requirements on the inspection capacity proof materials for newly applied enterprises who do not have self-inspection capacity?

The name of the inspection institutions and their legal qualification certification materials shall be submitted.

(1) Inspection institutions may be overseas official laboratories, third-party inspection institutions, etc., and applicants can entrust more than one inspection institutions for the inspections.

(2) The materials include the qualification certificates of the inspection institutions, the scope of inspection and testing, and the certification materials proving that they can carry out the inspections in accordance with relevant laws and regulations and the food safety national standards of infant formula milk powder.

8. If the applicant submits more than one sample labels of specifications, a confirmation letter shall be submitted as well. What are the main contents of the confirmation letter?

The content (except for net weight, consumption direction and shelf life etc.), format and color of specification label samples under the same recipe are consistent.

9. If the position of the figure in the label sample changes, whether it is necessary to submit a change application?

If there is no essential changes, namely, the formula change, the change of the graph position in the label sample, or the proportional expansion or reduction of the graph area (the graph style is not changed), the applicant can modify them by himself/herself, and it is not necessary to submit a change application.

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Contact Us
+353 1 477 3710 (EU)
+44 20 3239 9430 (UK)
+1 703 520 1420 (USA)
+86 571 8720 6574 (CN)
+82 2 6347 8816 (KR)