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Q&A Infant Formula Milk Powder Product Formula Registration (Certification Materials for R&D capability)

 
Q
What are the requirements for the research and development capability certification material "Research on nutrient attenuation during shelf life"?
A
In principle, the shelf life attenuation study should be carried out by the requirements of the "Guidelines for the Stability Research of Infant Formula Milk Powder Products (Trial)".
Q
What are the requirements for the research and development capability certification material "Research on nutrient design value and label value detection deviation range"?
A
Research on the deviation range of nutrient design value and label value detection should submit a study on the deviation range of nutrient design value and label value from the detection value.
 
Q
What are the requirements for the research and development capability certification material "Research on nutrient attenuation in the production process"?
A
(1) The research object should be 3 batches of this formula produced under commercial production conditions.
 
(2) The research content can be determined by itself based on production experience. All process types should at least include fats and fatty acids (linoleic acid, DHA, AA, etc.), water-soluble vitamins (VC, B1, B2, B12, folic acid, choline, etc.), fat-soluble vitamins (VE, VA, etc.), minerals (copper, zinc, iron, selenium, iodine, etc.) attenuation research.
 
(3) Research data should be self-inspected or issued by a qualified third-party inspection agency. For entrusted inspection, the principal shall be the applicant for registration of the formula.
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Q
What are the requirements for the research and development capability certification material "Research on Nutritional Data of Raw Materials"?
A
(1) Submit an inspection report (at least one batch) of bulk raw materials (including at least base powder, lactose, milk powder, whey powder, whey protein powder, raw milk, and vegetable oil) that provide protein, fat, and carbohydrates. The inspection items shall at least cover the requirements of raw material quality and safety standards. The base powder inspection items should also cover the requirements of the corresponding national food safety standards for infant formula milk powder.
 
Those who use the base powder shall provide the inspection report of the base powder, and the inspection report of the base powder ingredients can no longer be provided.
 
(2) The content data (at least 3 batches), the coefficient of variation statistical analysis and control measures of the essential nutrients indicated in the final product nutritional composition table of the final product and the optional ingredients in the bulk raw material background. Nutrients for which background content data are not provided in bulk raw materials (such as water-soluble vitamins in vegetable oils) should be fully justified. 
 
(3) The inspection report and background content data shall be issued by the applicant for self-inspection or by a qualified third-party inspection agency.
 
Q
What items are included in the R&D capability certification materials of the new applicant company?
A
At least it should include the determination basis of product nutrient design value and label value, research on raw material-related nutrition data, research on nutrient attenuation during production and shelf life, research on nutrient design value and label value detection deviation range, as well as formula composition selection basis and dosage design. There should be no missing items in the determination of value, formula verification and correction process and results, and product enterprise internal control standards.
 

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