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§70.45 着色剂容许用量的确定(Allocation of color additives)
2011-04-16 14:19  点击:2602
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:一种着色剂能否列入名单中或是否要更改现有的名单,或在专员对于不同剂量下各种用途的着色剂列入名单中的安全性尚未说明之前是否更改数据,每当考虑这些申请或建议时,专员将会在“联邦登记册”上发表公告,通知申请人和其它对其感兴趣的人对着色剂中的直接色素确定其安全用量数据是必须的。该公告要求所有对这一确定安全容许用量感兴趣的人根据本法规721(b)(8)要求提供数据。该申请的有效期限保持到直至这类安全用量被提交之日,之后时限再重新起算。在数据提交后尽可能快的时间内,专员会奉命宣布该安全用量确定的消息和容许用量的范围。

  § 70.45   Allocation of color additives.

  Whenever, in the consideration of a petition or a proposal to list a color additive or to alter an existing listing, the data before the Commissioner fail to show that it would be safe to list the color additive for all the uses proposed or at the levels proposed, the Commissioner will notify the petitioner and other interested persons by publication in the  Federal Register  that it is necessary to allocate the safe tolerance for the straight color in the color additive among the competing needs. This notice shall call for the presentation of data by all interested persons on which the allocation can be made in accordance with section 721(b)(8) of the act. The time for acting upon the petition shall be stayed until such data are presented, whereupon the time limits shall begin to run anew. As promptly as possible after presentation of the data, the Commissioner will, by order, announce the allocation and the tolerance limitations.

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上一篇:§70.42 评价着色剂安全性的依据(Criteria for evaluating the safety of color additives)