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Q&A Infant Formula Milk Powder Product Formula Registration (Quality and Technology)

 
Q
What are the requirements for the production capacity proof materials of the newly applied enterprise?
A
The production capacity proof materials of the newly applied enterprise shall include the following contents: 
 
(1) Submit the list of mandatory production equipment (including equipment parameters) and facilities, ensuring that the equipment and facilities comply with relevant laws and regulations. 
 
(2) Submit the surrounding environment map, production site plan and equipment layout map. 
 
(3) Submit the certificate or materials of the applicant's implementation of GMP requirements and implementation of HACCP system for powdered infant formula food.
 
Q
What method can be used on whey protein content detection? How should I submit the application materials?
A
For whey protein, since there is no national standard detection method at present, either calculation method or detection method can be used. 
 
(1) If the calculation method is used, the calculation formula, calculation process and the basis of the conversion coefficient of whey protein content in each raw material should be submitted (the protein content detection method of each raw material and formula product should be used by the national food safety standard); 
 
(2) For those using the detection method, the text of the detection method and the research and verification materials of methodology should be submitted, as well as the theoretical checking process of whey protein content.
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Q
The three batches of commercial trial products that manufactured according to the registered product formula, can the product inspection report of each batch be entrusted to different testing organization?
A
No. In order to ensure the comparability of inspection data between different batches of products, three batches of products with the same formula should be entrusted with the same testing organization.
 
Q
Does the product inspection report have to be submitted to a qualified inspection agency? What items does the product inspection report issued by testing organization include?  Do the inspection report format requirements also apply to foreign manufacturers?
A
(1) Product inspection report can be a self-inspection report or a commissioned inspection report. 
 
(2) The product inspection report issued by the testing organization includes at least all the inspection items with GB methods, and all items in the report should be issued by the same testing organization. 
 
(3) Yes, the format also applies to foreign manufacturers.
 
Q
Can non - GB methods be used in product inspection reports? Does the conclusion in product inspection report show the judgment that accords with GB requirement?​
A
(1) The testing method used in the product inspection report shall comply with the provisions of the national food safety standard for infant formula and relevant national standards. If there is no provision in the national standard, the applicant shall submit the test method text and the research and verification materials of methodology. The institution conducting the methodological research and validation should be the same institution that issued the test results for the project. 
 
(2) In addition to determining the requirements of the national standard, it is also necessary to determine the express value of the label.
 

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