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

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

Global FoodmateGlobal Foodmate21 Jan 2022

In what situations are there not significant differences between the formulations of the same applicant and the same age group?

The obvious difference means that it is aimed at the nutritional characteristics rather than the varieties of nutrients. The basis of product formula and its differences should be the results of breast milk research and nutritional research. The following situations are no obvious differences between the same applicant and the same age group formula:

(1) The variety and (or) amount of dietary fiber added are different, such as fructooligosaccharides, galactooligosaccharides, polyfructose, raffinose, polydextrose, yeast β-glucan, etc.;

(2) The variety and (or) amount of nucleotides added are different, such as 5'-monophosphate cytidine (5'-CMP), 5'-monophosphate uridine (5'-UMP), 5'-monophosphate adenosine ( 5'-AMP), 5'-inosinic acid disodium, disodium uridine-5-monophosphate, disodium 5'-guanylate, disodium cytidine-5’ monohposphate, etc.;

(3) Different species and (or) amounts of active bacteria added, such as Bifidobacterium animalis, Bifidobacterium lactis, Lactobacillus rhamnosus, Lactobacillus reuteri, Lactobacillus fermentum, Bifidobacterium breve and Lactobacillus acidophilus, etc.

How to submit the reference materials that prove the scientificity and safety of the formula?

The sufficient basis for proving the scientificity and safety of the formula can be: test data, relevant domestic and foreign regulations and standards, nutritional guidelines or monographs, nutritional data, other relevant research literature, and long-term market consumption history data, etc. For the use of the above materials, only the contents or abstracts of the relevant materials can be submitted.

If the same overseas applicant entrusts more than one agency for formula registration, is it necessary to submit a description of formula differences?

When the same applicant applies for the registration of two or more product formulas of the same age, an explanation of the differences between the formulas of the same age shall be submitted.

Are there any compliance requirements for food additive preparations that contain gum arabic, silicon dioxide, and sodium starch octenyl succinate as excipients?

Yes. The application materials should provide the use basis and compliance instructions for the use of excipients such as gum arabic, silicon dioxide, and sodium starch octenyl succinate in food additive preparations, and provide the calculation process.

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