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：按照法规409（c）（5）（C）中的规定，可用下述安全系数来判断某种食品添加剂的拟定用途是否安全：除用各种安全系数来衡量都证明是安全的之外，把由动物实验所得的安全系数应用于人类时，应取100比1，即某种用于人类的食品添加剂的容许用量乳超过对试验动物的最大无伤害量的1/100，则不会被批准使用。
§170.22 Safety factors to be considered
In accordance with section 409(c)(5)(C) of the Act, the following safety factors will be applied in determining whether the proposed use of a food additive will be safe: Except where evidence is submitted which justifies use of a different safety factor, a safety factor in applying animal experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be granted a tolerance that will exceed 1/100 th of the maximum amount demonstrated to be without harm to experimental animals.
In accordance with section 409(c)(5)(C) of the Act, the following safety factors will be applied in determining whether the proposed use of a food additive will be safe: Except where evidence is submitted which justifies use of a different safety factor, a safety factor in applying animal experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be granted a tolerance that will exceed 1/100 th of the maximum amount demonstrated to be without harm to experimental animals.
