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更多关于美国 FDA 21 CFR 第 73 部分的内容,请详见美国FDA 21 CFR 第73部分关于免除产品证书的食品用着色剂种类汇总
§ 73.350 Mica-based pearlescent pigments.
(a) Identity . (1) The color additive is formed by depositing titanium salts onto mica, followed by heating to produce titanium dioxide on mica. Mica used to manufacture the color additive shall conform in identity to the requirements of §73.1496(a)(1).
(2) Color additive mixtures for food use made with mica-based pearlescent pigments may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring food.
(b) Specifications . Mica-based pearlescent pigments shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:
(1) Lead (as Pb), not more than 4 parts per million (ppm).
(2) Arsenic (as As), not more than 3 ppm.
(3) Mercury (as Hg), not more than 1 ppm.
(c) Uses and restrictions . (1) The substance listed in paragraph (a) of this section may be safely used as a color additive in amounts up to 1.25 percent, by weight, in the following foods:
(i) Cereals.
(ii) Confections and frostings.
(iii) Gelatin desserts.
(iv) Hard and soft candies (including lozenges).
(v) Nutritional supplement tablets and gelatin capsules.
(vi) Chewing gum.
(2) The color additive may not be used to color foods for which standards of identity have been issued under section 401 of the act, unless the use of the added color is authorized by such standards.
(d) Labeling . The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification . Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[71 FR 31929, June 2, 2006]
§73.350 云母钛珠光颜料
(a)特性:
(1)此着色剂是通过在云母上涂钛盐,并加热产生二氧化钛而形成的。所用云母要具有§73.1496(a)(1)中所规定的特性。
(2)由云母钛珠光颜料制作的用于食物的着色剂混合物只能选用本分部中所列的合适的、能安全用于食品着色的着色剂混合物稀释剂。
(b)质量规格:云母钛珠光颜料应符合下列质量规格,除了指明的杂质在规定范围内之外,不得含有在现行GMP条件下可以避免的其它杂质。
(1)铅(以Pb计),不超过4mg/kg。
(2)砷(以As计),不超过3mg/kg。
(3)汞(以Hg计),不超过1mg/kg。
(c)使用和限制条件:
(1)在质量百分比含量不超过1.25%的情况下,本节(a)中所列的物质可被安全地用作下列食物的着色剂:
(i)谷物食品(Cereals)
(ii)甜点和挂霜糖(Confections and frostings)
(iii)果冻(Gelatin desserts)
(iv)硬糖和软糖(包括含片)
(v)营养补充片剂和胶囊
(vi)口香糖
(2)本着色剂不能用来对法规401部分中已确定标准的食品着色,除非所加入的色素是这类标准所允许的。
(d)标签标注方式:本着色剂和任何由本着色剂制备的混合物,拟单独使用或起部分着色效果时,其标签应符合本章§72.25中的规定。
(e)免除产品证书:本着色剂免除为保护公众健康而设的产品证书,所生产的每批产品也免除按法规§721(c)中规定的产品证书需求。
[71 FR 31929, June 2, 2006]
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