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保健食品辅料及用量的确定，需注意什么？

保健食品

2023-11-22

答：在确定保健食品辅料及用量时，申请人应充分考虑辅料的安全性、工艺必要性、保持产品稳定、与直接接触产品的包装材料不发生化学变化、不影响产品的检测、制剂成型性和稳定性等方面情况，提供辅料及用量的确定依据。此外，在产品原料投料量固定的前提下，辅料用量除应具有明确的工艺必要性和合理性外，还应确保不同批次终产品得量稳定一致。对于产品生产工艺包括提取工序的固体制剂，填充剂用量可为适量，液体制剂的稀释剂可为适量。

官方链接：国家市场监督管理总局食品审评中心

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