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

 
Q
If the registered formula needs to be adjusted according to the new national standard, under what circumstances does it need to be processed according to "change registration"?
A
The following situations shall be handled following the "Change Registration":
 
(1) Whole milk powder is adjusted to raw milk, skim milk powder is adjusted to skim milk, whey protein powder is adjusted to whey protein, and demineralized whey powder is adjusted to demineralized whey, etc. The solid-liquid properties of raw materials have changed;
 
(2) The varieties of main raw materials that provide macronutrients such as protein, fat and carbohydrate have been adjusted. For example, demineralized whey powder is adjusted to whey protein powder;
 
(3) There is animal origin in the product name, and the milk raw materials are adjusted to the same animal origin. For example, the desalted cow whey powder in the goat milk powder is adjusted to the desalted goat whey powder;
 
(4) The source of the compound of vitamins and minerals or the variety of food additives are adjusted. For example, retinyl acetate is adjusted to retinyl palmitate and potassium hydroxide is adjusted to potassium citrate;
 
(5) Monomer raw materials are adjusted to preparation raw materials or vice versa;
 
(6) The combination of raw materials is adjusted. For example, compound ingredients become monomeric raw materials;
 
(7) Maltodextrin, lactose and other raw material varieties as minor ingredients have been adjusted; 
 
(8) In the case of adjustment of the nutrient content item or labeled value in the nutrient composition table, except for the cancellation of the original formula and the application for a new formula;
 
(9) The original standard stipulated that it was an optional ingredient, but the new standard was adjusted to a required ingredient. And according to the new standard to increase the variety of raw materials or nutrients;
 
(10) Other situations that belong to the change of registration.
Q
What is the reasonable range of fluctuation or adjustment of raw materials in actual production? Does it need to be marked in the application materials?
A
On the premise that the types of raw materials remain unchanged, the order of the ingredients list and the content of nutrients meet the requirements, the amount of food raw materials and food additives used in actual production is allowed to fluctuate or adjust reasonably within a certain range. This range does not need to be marked in the application materials.
 
Q
What is the relationship between the product formulation submitted in the registration application and the product formulation used for commercial trial production process validation?
A
The product formula submitted by the applicant for registration shall be consistent with the product formula used for commercial trial production process verification.
 

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