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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 評價著色劑安全性的依據
（a）在決定一項申請是否完全適于登記存檔，和對已登記存檔的申請做出決議時，專員應當采用"安全供使用"原則。這原則要求提供必需的所有科學數據，以支持建議投入使用的列入名單中的產品，確保列入名單的著色劑對于其擬定的用途或用在食品、藥品或化妝品上是安全的。當專員從提交的數據中發現該著色劑用于或用在食品上、用于或用在藥品上、用于或用在化妝品上的一般用途是合適的，也可能是安全的，他就可以將該著色劑列入名單中；他可以將已經證明使用是適當的和安全的但用途更為有限的著色劑列入名單中；他還有權規定該著色劑安全使用的條件。這就允許各種顏料、色素或其它僅帶有稀釋劑（但不帶有其它成分的物質，或帶有較高濃度的其它成分）的物質可以使用。
（b）外用著色劑的安全性是通過口服急性毒性、初始刺激、過敏、無損傷和已擦傷皮膚的亞急性皮膚毒性，以及皮膚致癌性試驗來確定的。若專員確信無需采用這類試驗來確定擬定用途的安全性數據時，他可以免除這類試驗中的任何內容。
（c）在起草描述某一著色劑擬議中的用途和為確定該著色劑安全性所計劃的實驗的請求信時，專員可以向希望確定某著色劑安全性的人提出建議，使計劃好的實驗方案得出可供評估該著色劑安全性的足夠數據。
