§70.42 评价着色剂安全性的依据(Criteria for evaluating the safety of color additives)

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   　　§ 70.42   Criteria for evaluating the safety of color additives.

　　（a） In deciding whether a petition is complete and suitable for filing and in reaching a decision on any petition filed, the Commissioner will apply the “safe-for-use” principle. This will require the presentation of all needed scientific data in support of a proposed listing to assure that each listed color additive will be safe for its intended use or uses in or on food, drugs, or cosmetics. The Commissioner may list a color additive for use generally in or on food, in or on drugs, or in or on cosmetics when he finds from the data presented that such additive is suitable and may safely be employed for such general use; he may list an additive only for more limited use or uses for which it is proven suitable and may safely be employed; and he is authorized to prescribe broadly the conditions under which the additive may be safely employed for such use or uses. This may allow the use of a particular dye, pigment, or other substance with certain diluents, but not with others, or at a higher concentration with some than with others.

　　（b） The safety for external color additives will normally be determined by tests for acute oral toxicity, primary irritation, sensitization, subacute dermal toxicity on intact and abraded skin, and carcinogenicity by skin application. The Commissioner may waive any of such tests if data before him otherwise establish that such test is not required to determine safety for the use proposed.

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

　　§70.42　评价着色剂安全性的依据

　　（a）在决定一项申请是否完全适于登记存档，和对已登记存档的申请做出决议时，专员应当采用"安全供使用"原则。这原则要求提供必需的所有科学数据，以支持建议投入使用的列入名单中的产品，确保列入名单的着色剂对于其拟定的用途或用在食品、药品或化妆品上是安全的。当专员从提交的数据中发现该着色剂用于或用在食品上、用于或用在药品上、用于或用在化妆品上的一般用途是合适的，也可能是安全的，他就可以将该着色剂列入名单中；他可以将已经证明使用是适当的和安全的但用途更为有限的着色剂列入名单中；他还有权规定该着色剂安全使用的条件。这就允许各种颜料、色素或其它仅带有稀释剂（但不带有其它成分的物质，或带有较高浓度的其它成分）的物质可以使用。

　　（b）外用着色剂的安全性是通过口服急性毒性、初始刺激、过敏、无损伤和已擦伤皮肤的亚急性皮肤毒性，以及皮肤致癌性试验来确定的。若专员确信无需采用这类试验来确定拟定用途的安全性数据时，他可以免除这类试验中的任何内容。

　　（c）在起草描述某一着色剂拟议中的用途和为确定该着色剂安全性所计划的实验的请求信时，专员可以向希望确定某着色剂安全性的人提出建议，使计划好的实验方案得出可供评估该着色剂安全性的足够数据。