Q: What should be paid attention to in the determination of health food auxiliary materials and dosage?

A: When determining the auxiliary materials and dosage of health food, the applicant should fully consider the safety of auxiliary materials, the necessity of the process, the stability of the product, no chemical changes with the packaging materials in direct contact with the product and the detection, dosage formability and stability of the product, and should provide the basis for determining the auxiliary materials and dosage. In addition, under the premise of a fixed amount of product raw materials, the dosage of auxiliary materials should not only have a clear process necessity and rationality, but the amount of final products in different batches should also be ensured to be stable and consistent. For solid preparations for which the product production process includes extraction processes, the dosage of filler may be appropriate and the diluent for liquid preparations may be appropriate.

Source: SAMR

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Relevant reading

l Q&A| Application of HF Raw Materials Nutrient Supplement 2023

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