21 CFR § 170.22 - Safety factors to be considered.

§ 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 1/100th of the maximum amount demonstrated to be without harm to experimental animals.

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