当前位置: 首页 » 政策法规 » 国外法规 »§80.35 混合着色剂及其认证和认证豁免(Color additive mixtures; certification and exemption from certification)

§80.35 混合着色剂及其认证和认证豁免(Color additive mixtures; certification and exemption from certification)

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放大字体  缩小字体 2011-09-15 13:40:46  来源:GPO  浏览次数:3169
核心提示:混和着色剂包含一种或几种本章74部分列出的纯色着色剂,预计用于食品、药品或化妆品或人体彩绘的需要进行认证;一种或者几种已获认证的纯色着色剂使用时组成没有变化或简单地与已获批准的稀释剂混合制得的混和着色剂豁免其认证;需要使用稀释剂的则根据本章§71.1部分提出申请。
发布单位
FDA
FDA
发布文号 29 FR 18495
发布日期 暂无 生效日期 暂无
有效性状态 废止日期 暂无
备注 混和着色剂包含一种或几种本章74部分列出的纯色着色剂,预计用于食品、药品或化妆品或人体彩绘的需要进行认证;一种或者几种已获认证的纯色着色剂使用时组成没有变化或简单地与已获批准的稀释剂混合制得的混和着色剂豁免其认证;需要使用稀释剂的则根据本章§71.1部分提出申请。

  § 80.35   Color additive mixtures; certification and exemption from certification.

  (a) Color additive mixtures to be certified. Any color additive mixture that contains one or more straight colors listed in part 74 of this chapter, together with any diluents listed in such subparts for use with such straight colors, shall be certified if intended for use in foods, drugs, or cosmetics, or in coloring the human body, as the case may be, subject to any restriction prescribed in parts 70 and 71 of this chapter.

  (b) Color additive mixtures exempted from certification. A color additive mixture prepared from a previously certified batch of one or more straight colors, with or without any diluent that has been listed in part 73 of this chapter for use in mixtures, shall be exempt from batch certification if the straight color used has not changed in composition in any manner whatsoever since its certification and if it is simply mixed with the approved diluents for exempt mixtures. The label of such color additive mixtures shall not bear the lot number assigned by the Food and Drug Administration to the certified straight color components, but shall bear the manufacturer's control number through which the history of the straight color can be determined.

  (c) Additions to the list of diluents. A person requesting additions to the list of diluents authorized for the purposes described in paragraphs (a) and (b) of this section shall submit a petition in accordance with the provisions of §71.1 of this chapter. Each such petition shall be accompanied by the fee prescribed in §70.19 of this chapter, unless there is an advance deposit to be used for prepayment of such fees.

  Note: The provisions of §80.35 with respect only to diluents for use in cosmetic color additive mixtures were stayed, until a regulation is effected listing safe diluents for cosmetic use, including cosmetics which color the human body, 29 FR 18495, Dec. 29, 1964.

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