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§71.20 规章的发?publication of regulation)

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放大字体缩小字体2011-09-01 01:29:56 来源:GPO 浏览次数9span id="hits">2533
核心提示:受理专员在申请归档90天之内可将其公布在美国联邦公报上(如果需要延期的则要?80天内),73?4部分关于着色剂适用列表的规章应列出其适用范围、安全使用条件;当受理专员认为该认证对保护公共安全为非必需时,他会依照顺序批准该着色剂豁免于认证程序,在决定一种着色剂认证是否必要时,会考虑其组成、生产工艺、可能出现的杂质、潜在毒性、遵循列表规定的控制和分析程序以及组成的多样性、/div>
发布单位
FDA
FDA
发布文号 65 FR 51762
发布日期 2000-08-25 生效日期 暂无
有效性状?/th> 废止日期 暂无
备注 受理专员在申请归?0天之内可将其公布在美国联邦公报上(如果需要延期的则要?80天内),73?4部分关于着色剂适用列表的规章应列出其适用范围、安全使用条件;当受理专员认为该认证对保护公共安全为非必需时,他会依照顺序批准该着色剂豁免于认证程序,在决定一种着色剂认证是否必要时,会考虑其组成、生产工艺、可能出现的杂质、潜在毒性、遵循列表规定的控制和分析程序以及组成的多样性、/td>

更多关于着色剂使用申请的法规,请详?a target="_blank" href="//www.sqrdapp.com/law/dongtai/173325.html">美国FDA 21 CFR ?1部分关于着色剂使用申请的法规汇怺/font>、br />
   71.20 Publication of regulation.

  The Commissioner will forward for publication in the Federal Register,within 90 days after filing of the petition (or within 180 days if the time is extended as provided for in section 721(d)(1 of the act(

  (a A regulation listing in part 73 or 74 of this chapter the color additive on the appropriate list or lists as provided under section 721(b)(1?

  ? Such a regulation may list the color additive for use generally in or on foods, drugs, or cosmetics or for use in coloring the human body, as the case may be, or may prescribe the conditions under which the color additive may be safely used (including, but not limited to, specifications as to the particular food, drug, or cosmetic or classes of food, drugs, or cosmetics in or on which such color additive may be used, or for the material intended for coloring the human body; the maximum quantity of any straight color or diluent that may be used or permitted to remain in or on such food, drug, or cosmetic or article intended for coloring the human body; the manner in which such color additive may be added to or used in or on such food, drug, or cosmetic or for coloring the human body; and any directions or other labeling or packing requirements for such color additives deemed necessary to assure the safety of such use?

  ? Such regulations shall list the color additive only for the use or uses for which it has been found suitable and for which it may safely be employed. Alternatively, the Commissioner shall by order deny the petition, and notify the petitioner of such order and the reasons therefor.

  ? The regulation shall list any use or uses in meat, meat food product, or poultry product subject to the Federal Meat Inspection Act (FMIA ?1 U.S.C. 601 et seq . or the Poultry Products Inspection (PPIA ?1 U.S.C. 451 et seq . for which the color additive has been found suitable and for which it may safely be employed.

  (b Whenever the Commissioner finds that batch certification is not necessary for the protection of the public health he will, by order, exempt the color additive from the certification procedure. In determining whether certification of a color additive is necessary, the Commissioner will consider the composition of the additive, its manufacturing process, possible impurities, its toxic potential, control and analytical procedures necessary to assure compliance with the listing specifications, and the variability of its composition.

  [42 FR 15639, Mar. 22, 1977, as amended at 65 FR 51762, Aug. 25, 2000]

地区9/font>美国
标签9/font>规章豁免着色剂认证
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