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对于无适用的国家标准、地方标准、行业标准的原料，申报时如何提供原料的生产工艺、质量标准等相关资料？

保健食品原料

2023-11-22

答：对于无适用的国家标准、地方标准、行业标准的原料，申请人应提供该原料详细的制备工艺、工艺说明及工艺合理性依据，并符合以下要求：

（1）制备工艺流程简图应完整、规范，并与工艺说明相一致。各工序的卫生洁净级别（或划分洁净区范围）应在工艺简图中标明。

（2）工艺合理性依据应能充分说明原料制备工艺所列主要工序与关键参数的合理性、可行性。必要时应提供文献和/或试验依据。

（3）原料的制备工艺应与原料质量要求、质检报告相关内容相符。

官方链接：国家市场监督管理总局食品审评中心

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