The “Health Food Ingredient Directory Soy Protein Isolate” and the “Health Food Ingredient Directory Whey Protein” officially took effect from October 1, 2023. The following answers are given for the related issues of the above two health food ingredients records.
1. What materials should be provided when soy protein isolate and/or whey protein need to be matched with nutrients during product filing?
The record holder should provide data with the same formulation materials and the same health function as the approved product. The same formula ingredient information refers to the ingredient names and types identical to those in the “Ingredients” section of the approved product’s label. The record product should not increase or decrease the ingredient names and types of the approved product. The same health function information refers to including the efficacy in this ingredient catalog, at least, under the “health function” item of the approved product label.
2. How to handle if soy protein isolate and/or whey protein use a formula that has not been used in an approved product when they need to be matched with nutrients during the product filing?
If nutrients need to be matched and a formula that has not been used in the approved product is used, management according to registered products.
3. What should be paid attention to during the process of transferring protein product registration to filing?
The types of formulation ingredients should not be changed during the product filing for the products converted from registration to filing. For products with nutrient supplements, the dosage of nutrients should not be higher than the maximum daily dosage for the corresponding population in the health food raw material directory, and the claim of health function should only be “enhance immunity”. The precautions should also meet the requirements of the nutrient supplement health food ingredient directory.If the approved product’s material type, health function is the same, but the dosage, dosage form, excipients, etc. do not meet the technical requirements for filing, the product should be adjusted to meet the related technical requirements and transferred to the recording management. The person also needs to provide a commitment to the product’s safety, effectiveness, and quality controllability.
4. How to label the health function when health food with functional properties made from soy protein isolate and/or whey protein is recorded?
When health food with functional properties made from ingredients such as soy protein isolate and/or whey protein is filed, the record product should follow the effects in the published health food ingredient directory and combine the adjusted health function claims in the newly published allowed health food claim directory. The label should be “helpful in enhancing immunity”. (Source: Beijing Market Supervision )
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