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实验动物获得市场可食产品的认可程序及其研究使用的豁免 (Exemption for investigational use and procedure for obtaining authorizat

发布日期:2014-07-16  浏览次数:1346
   【发布单位】 FDA

  【发布文号】 43 FR 60023

  【发布日期】 1978-12-22

  【生效日期】

  【废止日期】

  【替代法规】

  【效  力】 有效

  【解读】 合格专家认为可供研究使用的食品添加剂或含有该食品添加剂的食品需要在以下情况下豁免法案第409部分的要求:用于实验室动物或体外研究的,需要在法案所规定的信息上显著注明警示(含有一种新型食品添加剂,仅用于了实验室动物或体外实验,而不适用于人类);用于动物且被FDA认定为食品的,需要有明确标注(含有一种新型食品添加剂,仅用于了实验室动物,而不适用于人类);供食用的动物的非临床试验研究应遵照本章第58部分的规定进行。

  更多关于食品添加剂的法规,请详见美国FDA 21 CFR 第570部分关于食品添加剂的法规汇总。

  § 570.17 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.

  [41 FR 38644, Sept. 10, 1976, as amended at 43 FR 60023, Dec. 22, 197



    
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