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§ 570.20 食品添加剂安全性评估的总体原则 (General principles for evaluating the safety of food additives)
2011-09-05 17:14  点击:3600
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:专员需要根据美国国家科学院国家研究理事会现存出版物中所阐明的原则和程序对食品添加剂的安全性进行评估,并充分考虑化合物的特殊生物活性和表明其使用安全方法的充分性,在此基础上对申请作出判断。关于提出书面说明建议使用的添加剂和建议实验以确定其安全性,专员会征询渴望证实食品添加剂安全性人员的意见,评估所产生数据的充分性。

      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

  § 570.20   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 inferable. For the purposes of this section, the principles for evaluating safety of additives set forth in the above-mentioned 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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