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§170.17 对供研究性用途免除申报和根据实验动物的试验结果获准在市场上销售的可食产品的审批程序
2011-09-25 20:46  点击:2364
发布单位:FDA
发布文号:43 FR 60021
发布日期:1978-12-22
生效日期:暂无
有效性状态:
废止日期:暂无
备注:下列三种情况下可免除409节中的要求:如用于试管或实验研究动物做研究性用途,标签上除法规规定的其他资料说明外,还应标上“注意:其中含有一种只供实验室研究动物或在试管中做试验使用的新的食品添加剂,不得用于人类”;如用于实验研究的动物外地动物,以及获准在市场上作为食品销售的该动物的可食用产品,提案人已提出审批要求,FDA发布了批准授权;用于食用性动物的非临床试验研究,该研究应按本章第58部分中的规定进行。

     §170.17 Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.

       A food additive or food containing a food additive intended for investigational use by qualified experts shall be exempt from the requirements of section 409 of the Act under the following conditions:

  (a) If intended for investigational use in vitro or in laboratory research animals, it bears a label which states prominently, in addition to the other information required by the act, the warning:

  Caution. Contains a new food additive for investigational use only in laboratory research animals or for tests in vitro. Not for use in humans.

  (b) If intended for use in animals other than laboratory research animals and if the edible products of the animals are to be marketed as food, permission for the marketing of the edible products as food has been requested by the sponsor, and authorization has been granted by the Food and Drug Administration in accordance with § 511.1 of this chapter or by the Department of Agriculture in accordance with 9 CFR 309.17, and it bears a label which states prominently, in addition to the other information required by the Act, the warning:

  Caution. Contains a new food additive for use only in investigational animals. Not for use in humans.

  Edible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Food and Drug Administration or by the U.S. Department of Agriculture.

  (c) If intended for nonclinical laboratory studies in food-producing animals, the study is conducted in compliance with the regulations set forth in part 58 of this chapter.

   [42 FR 14483, Mar. 15, 1977, as amended at 43 FR 60021, Dec. 22, 1978]

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下一篇:§170.18 相关食品添加剂的容许量(Tolerances for related food additives)
上一篇:§170.15 关于采纳FDA局长建议的规定(Adoption of regulation on initiative of Commissioner)
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