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§172.870 食品添加剂羟丙基纤维素(Hydroxypropyl cellulose)

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放大字体  缩小字体 2011-05-03 02:14:49  来源:GPO  浏览次数:3968
核心提示:规定了食品添加剂羟丙基纤维素安全应用于食品中需符合的条件。符合本节(a)(1)所规定添加剂,可用做乳化剂、成膜剂、保护性胶体、稳定剂、悬浮剂或增稠剂,按GMP要求使用。符合本节(a)(2)所规定添加剂,可用做粘结剂、片剂的崩解剂、含有维生素和/或无机盐之类营养增补剂的薄片的崩解剂,本添加剂的用法按GMP要求。
发布单位
FDA
FDA
发布文号 46 FR 50065
发布日期 1981-10-09 生效日期 暂无
有效性状态 废止日期 暂无
备注 规定了食品添加剂羟丙基纤维素安全应用于食品中需符合的条件。符合本节(a)(1)所规定添加剂,可用做乳化剂、成膜剂、保护性胶体、稳定剂、悬浮剂或增稠剂,按GMP要求使用。符合本节(a)(2)所规定添加剂,可用做粘结剂、片剂的崩解剂、含有维生素和/或无机盐之类营养增补剂的薄片的崩解剂,本添加剂的用法按GMP要求。

  § 172.870   Hydroxypropyl cellulose.

  The food additive hydroxypropyl cellulose may be safely used in food, except standardized foods that do not provide for such use, in accordance with the following prescribed conditions:

  (a) The additive consists of one of the following:

  (1) A cellulose ether containing propylene glycol groups attached by an ether linkage which contains, on an anhydrous basis, not more than 4.6 hydroxypropyl groups per anhydroglucose unit. The additive has a minimum viscosity of 145 centipoises for 10 percent by weight aqueous solution at 25 °C.

  (2) A cellulose ether containing propylene glycol groups attached by an ether linkage having a hydroxypropoxy (OC3H6OH) content of 5 to 16 percent weight in weight (w/w) on an anhydrous basis, i.e., 0.1 to 0.4 hydroxypropyl groups per anhydroglucose unit. The common name for this form of the additive is low substituted hydroxypropyl cellulose.

  (b) The additive is used or intended for use as follows:

  (1) The additive identified in paragraph (a)(1) of this section is used or intended for use as an emulsifier, film former, protective colloid, stabilizer, suspending agent, or thickener, in accordance with good manufacturing practice.

  (2) The additive identified in paragraph (a)(2) of this section is used or intended for use as a binder and disintegrator in tablets or wafers containing dietary supplements of vitamins and/or minerals. The additive is used in accordance with good manufacturing practice.

  [46 FR 50065, Oct. 9, 1981]

  更多关于美国 FDA 已批准的直接用于人类食品的添加剂种类法规,请点击美国FDA 21 CFR 第172部分已批准的直接用于人类食品的添加剂种类汇总

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