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    　　§ 70.50   Application of the cancer clause of section 721 of the act.

　　（a） Color additives that may be ingested. Whenever （1） the scientific data before the Commissioner （either the reports from the scientific literature or the results of biological testing） suggest the possibility that the color additive including its components or impurities has induced cancer when ingested by man or animal; or （2） tests which are appropriate for the evaluation of the safety of additives in food suggest that the color additive, including its components or impurities, induces cancer in man or animal, the Commissioner shall determine whether, based on the judgment of appropriately qualified scientists, cancer has been induced and whether the color additive, including its components or impurities, was the causative substance. If it is his judgment that the data do not establish these facts, the cancer clause is not applicable; and if the data considered as a whole establish that the color additive will be safe under the conditions that can be specified in the applicable regulation, it may be listed for such use. But if in the judgment of the Commissioner, based on information from qualified scientists, cancer has been induced, no regulation may issue which permits its use.

　　（b） Color additives that will not be ingested. Whenever the scientific data before the Commissioner suggest the possibility that the color additive, including its components or impurities, has induced cancer in man or animals by routes other than ingestion, the Commissioner shall determine whether, based on the judgment of appropriately qualified scientists, the test suggesting the possibility of carcinogenesis is appropriate for the evaluation of the color additive for a use which does not involve ingestion, cancer has been induced, and the color additive, including its components or impurities, was the causative substance. If it is his judgment that the data do not establish these facts, the cancer clause is not applicable to preclude external drug and cosmetic uses, and if the data as a whole establish that the color additive will be safe under conditions that can be specified in the regulations, it may be listed for such use. But if, in the judgment of the Commissioner, based on information from qualified scientists, the test is an appropriate one for the consideration of safety for the proposed external use, and cancer has been induced by the color additive, including its components or impurities, no regulation may issue which permits its use in external drugs and cosmetics.

　　（c） Color additives for use as an ingredient of feed for animals that are raised for food production. Color additives that are an ingredient of the feed for animals raised for food production and that have the potential to contaminate human food with residues whose consumption could present a risk of cancer to people must satisfy the requirements of subpart E of part 500 of this chapter.

　　[42 FR 15636, Mar. 22, 1977, as amended at 43 FR 22675, May 26, 1978; 52 FR 49586, Dec. 31, 1987]

　　§70.50　本法规721节癌症条款的应用

　　（a）内服的着色剂：每当（1）专员面前的科学数据（或者根据科学文献报道或者根据生物实验结果）表明在通过人或者动物内服了包括其成分或杂质在内的着色剂后存在致癌的可能性，或（2）在食品中使用添加剂的安全性试验表明该着色剂（包括它的各种成分或杂质在内）在人体或动物体内会致癌，专员可以依据有资格的科学家的评价做出该着色剂是否会引发癌症，包括其各种成分或杂质在内，是或不是致癌物质的判定。如果他判定这些数据未能确定这些事实，则不能应用癌症条款；如果所考虑的数据从总体上确定了该着色剂在可适用规定的条件下是安全的，则它可以列入名单中以供这类用途。但如果专员依据来自有资格的科学家的资料数据，判定它会引发癌症，则按规定不得签发这种着色剂的使用许可。

　　（b）不会被内服的着色剂：每当摆在专员面前的科学数据表明，着色剂（包括它的各种成分或杂质在内）通过除内服之外的程序使用，在人体或动物体内存在致癌可能性，专员会依据有资格的科学家的评价，和致癌可能性的试验结果，判定其是否会引发癌症，同时确定该着色剂（包括它的成分和杂质在内）是否属于致癌物质。如果他判定有关数据不能确定这些事实，则不应将癌症条款用来排除着色剂在外用药和化妆品中使用；如果有关数据作为一个整体确定该着色剂在规定范围内的指定条件下是安全的，它可以被列入名单中以供相关用途使用。但是如果专员依据有资格的科学家的资料数据，而且拟定外用的安全性试验也是正确的。该着色剂（包括其成分和杂质在内）已引发了癌症，则按规定不得签发它在药物和化妆品中使用的许可。

　　（c）用于喂养供人类食用的动物的饲料成分的着色剂：用于喂养供人类食用的动物的饲料成分的着色剂，和可能存在的残留物污染食品后会给人类带来癌症风险的着色剂，必须满足本章500部分E分部中的要求。