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§71.25 认证条件(condition for certification)
2011-09-01 15:01  点击:3609
发布单位:FDA
发布文号:暂无
发布日期:暂无
生效日期:暂无
有效性状态:
废止日期:暂无
备注:当受理专员不能从申请材料信息中得出豁免该着色剂免于认证要求的结论时,他会在本章第74部分规定下将该着色剂编入列表中,专员的命令须详细说明着色剂应符合的质量规格。

      更多关于着色剂使用申请的法规,请详见美国FDA 21 CFR 第71部分关于着色剂使用申请的法规汇总

  § 71.25   Condition for certification.

  (a) When the Commissioner cannot conclude from the information before him that there is a basis for exempting a color additive from the requirement of batch certification, he will so order by appropriate listing in part 74 of this chapter. The Commissioner's order shall state in detail the specifications that shall be met by the color additive.

  (b) Each order shall state a period of time after which use of a color additive subject to batch certification but not from a batch certified by procedure prescribed in this section would result in adulteration of the product in which it is used.

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