§70.10 着色剂在标准化食品、新药和抗菌素中的使用(Color additives in standardized foods and new drugs)

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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.

　　（2） 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.

　　（3） 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.

　　（b） 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.

　　（3） 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　着色剂在标准化食品、新药和抗菌素中的使用

　　（a）标准化食品：

　　（1）在一项有关请求颁布或修订本法规401节（其中提到标准化食品中着色剂的内容）中有关一种食品特性的标准和定义的申请被接受后，则本章第71部分中规定的条款应当适用于着色剂的安全性必须符合的有关资料数据（如果这类资料数据未曾提交过，以及拟定用途的该着色剂的安全性数据尚未确立），该申请同时还要表明，该着色剂在标准化食品中的使用是符合本法规401节的，或者是符合本章§130.17中颁布的临时许可条款。

　　（2）如果一项有关特性的定义和标准的申请包含一项着色剂规定的建议，而申请人未将其写明，则专员在做出有关这一包括着色剂规定在内的申请的决定时，应当立即通知申请者，并且应当根据本章第 71部分的规定执行后续程序。

　　（3）一种食品着色剂，即使其特性的定义和标准已经确定，但如果不符合本法规401节或者不符合在本章§130.17内容下颁布的临时许可条款，则此添加剂的有关规定仍不能颁布，即不容许将它用于食品。在该着色剂的拟定用途符合临时许可条款时，该着色剂的有关规定应当符合这些条款，并且将按临时许可条款的有效期为准。

　　（b）新药：

　　（1）在一项新药许可证的申请被受理，且该项申请仅是有关着色剂的应用，如果这类资料数据以前未被提交过，对于拟定用途的该着色剂的安全性数据尚未确立，则本章第71部分规定中的条款应当适用于着色剂安全性必须符合有关资料数据的规定。

　　（2）如果一项新药的申请隐含着一项着色剂规定的建议，而申请人未将其写明，则专员在做出有关这一着色剂的规定在内的申请决定时，应当立即通知申请者，并且应当根据本章71部分的规定执行后续程序。

　　（3）在一项有关着色剂的申请必须按照本节（b）（2）规定存档的情况下，该着色剂申请存档的日期应当以该新药申请的存档日期为准。