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§ 70.10 Color additives in standardized foods and new drugs.
（a） Standardized foods. （1） Where a petition is received for issuance or amendment of a regulation establishing a definition and standard of identity for a food under section 401 of the act, which proposes the inclusion of a color additive in the standardized food, the provisions of the regulations in part 71 of this chapter shall apply with respect to the information that must be submitted with respect to the safety of the color additive （if such information has not previously been submitted and safety of the color additive for the intended use has not been already established）, and the petition must show also that the use of the color additive in the standardized food would be in conformance with section 401 of the act or with the terms of a temporary permit issued under §130.17 of this chapter.
?。?） If a petition for a definition and standard of identity contains a proposal for a color additive regulation, and the petitioner fails to designate it as such, the Commissioner, upon determining that the petition includes a proposal for a color additive regulation, shall so notify the petitioner and shall thereafter proceed in accordance with the regulations in part 71 of this chapter.
?。?） A regulation will not be issued allowing the use of a color additive in a food for which a definition and standard of identity is established, unless its issuance is in conformance with section 401 of the act or with the terms of a temporary permit issued under §130.17 of this chapter. When the contemplated use of such additive complies with the terms of a temporary permit, the color additive regulation will be conditioned on such compliance and will expire with the expiration of the temporary permit.
?。╞） New drugs. （1） Where an application for a new drug is received and this application proposes, for coloring purposes only, the inclusion of a color additive, the provisions of the regulations in part 71 of this chapter shall apply with respect to the information that must be submitted about the safety of the color additive, if such information has not previously been submitted and safety of the color additive for the intended use has not already been established.
（2） If an application for a new drug inferentially contains a proposal for a color additive regulation, and the applicant fails to designate it as such, the Commissioner, upon determining that the application includes a proposal for a color additive regulation, shall so notify the applicant and shall thereafter proceed in accordance with the regulations in part 71 of this chapter.
?。?） Where a petition for a color additive must be filed in accordance with paragraph （b）（2） of this section, the date of filing of the color additive petition shall be considered as the date of filing of the new-drug application.
[42 FR 15636, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999]
§70.10 著色劑在標準化食品、新藥和抗菌素中的使用
?。╝）標準化食品：
?。?）在一項有關請求頒布或修訂本法規(guī)401節(jié)（其中提到標準化食品中著色劑的內容）中有關一種食品特性的標準和定義的申請被接受后，則本章第71部分中規(guī)定的條款應當適用于著色劑的安全性必須符合的有關資料數(shù)據（如果這類資料數(shù)據未曾提交過，以及擬定用途的該著色劑的安全性數(shù)據尚未確立），該申請同時還要表明，該著色劑在標準化食品中的使用是符合本法規(guī)401節(jié)的，或者是符合本章§130.17中頒布的臨時許可條款。
?。?）如果一項有關特性的定義和標準的申請包含一項著色劑規(guī)定的建議，而申請人未將其寫明，則專員在做出有關這一包括著色劑規(guī)定在內的申請的決定時，應當立即通知申請者，并且應當根據本章第 71部分的規(guī)定執(zhí)行后續(xù)程序。
?。?）一種食品著色劑，即使其特性的定義和標準已經確定，但如果不符合本法規(guī)401節(jié)或者不符合在本章§130.17內容下頒布的臨時許可條款，則此添加劑的有關規(guī)定仍不能頒布，即不容許將它用于食品。在該著色劑的擬定用途符合臨時許可條款時，該著色劑的有關規(guī)定應當符合這些條款，并且將按臨時許可條款的有效期為準。
?。╞）新藥：
?。?）在一項新藥許可證的申請被受理，且該項申請僅是有關著色劑的應用，如果這類資料數(shù)據以前未被提交過，對于擬定用途的該著色劑的安全性數(shù)據尚未確立，則本章第71部分規(guī)定中的條款應當適用于著色劑安全性必須符合有關資料數(shù)據的規(guī)定。
?。?）如果一項新藥的申請隱含著一項著色劑規(guī)定的建議，而申請人未將其寫明，則專員在做出有關這一著色劑的規(guī)定在內的申請決定時，應當立即通知申請者，并且應當根據本章71部分的規(guī)定執(zhí)行后續(xù)程序。
?。?）在一項有關著色劑的申請必須按照本節(jié)（b）（2）規(guī)定存檔的情況下，該著色劑申請存檔的日期應當以該新藥申請的存檔日期為準。
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編輯：foodfagui