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§170.20 评价食品添加剂安全性的基本原理(General principles for evaluating the safety of food additives)

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放大字体  缩小字体 2011-09-26 08:26:49  来源:GPO  浏览次数:2562
核心提示:凡对在法规409节范围内的决定提出任何建议,FDA局长均会给予充分的考虑,包括化合物的特殊生物学性质和采用适当的方法以证实所建议的用途的安全性,才外,局长还应依据国家科学研究院/国家研究委员会现行出版物中发表的,为确定食品添加剂安全性所规定的原理和实际操作程序,给予指导。在某人就添加剂的拟定应用和拟通过试验已决定其安全性而提出书面申请时,局长会向这位希望确定食品添加剂安全数据的人提出建议。
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备注 凡对在法规409节范围内的决定提出任何建议,FDA局长均会给予充分的考虑,包括化合物的特殊生物学性质和采用适当的方法以证实所建议的用途的安全性,才外,局长还应依据国家科学研究院/国家研究委员会现行出版物中发表的,为确定食品添加剂安全性所规定的原理和实际操作程序,给予指导。在某人就添加剂的拟定应用和拟通过试验已决定其安全性而提出书面申请时,局长会向这位希望确定食品添加剂安全数据的人提出建议。

      §170.20 General principles for evaluating the safety of food additives.

      (a) In reaching a decision on any petition filed under section 409 of the Act, the Commissioner will give full consideration to the specific biological properties of the compound and the adequacy of the methods employed to demonstrate safety for the proposed use, and the Commissioner will be guided by the principles and procedures for establishing the safety of food additives stated in current publications of the National Academy of Sciences-National Research Council. A petition will not be denied, however, by reason of the petitioner's having followed procedures other than those outlined in the publications of the National Academy of Sciences-National Research Council if, from available evidence, the Commissioner finds that the procedures used give results as reliable as, or more reliable than, those reasonably to be expected from the use of the outlined procedures. In reaching a decision, the Commissioner will give due weight to the anticipated levels and patterns of consumption of the additive specified or reasonably inferrable. For the purposes of this section, the principles for evaluating safety of additives set forth in the abovementioned publications will apply to any substance that may properly be classified as a food additive as defined in section 201(s) of the Act.

  (b) Upon written request describing the proposed use of an additive and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will yield data adequate for an evaluation of the safety of the additive.

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