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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
§ 73.345 Paprika oleoresin.
(a) Identity. (1) The color additive paprika oleoresin is the combination of flavor and color principles obtained from paprika ( Capsicum annuum L.) by extraction, using any one or a combination of the following solvents:
Acetone
Ethyl alcohol
Ethylene dichloride
Hexane
Isopropyl alcohol
Methyl alcohol
Methylene chloride
Trichloroethylene
The definition of paprika oleoresin in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for paprika oleoresin under section 401 of the act.
(2) Color additive mixtures made with paprika oleoresin may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b) Specifications. Paprika oleoresin shall contain no more residue of the solvents listed in paragraph (a)(1) of this section than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in parts 170 through 189 of this chapter.
(c) Uses and restrictions. Paprika oleoresin may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.
(d) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions 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.
§73.345 红辣椒油树脂
(a)特性:
(1)着色剂红辣椒油树脂,是以香味料和色素为主的复合物,由红辣椒(Capsicum annuum L.)用下列溶剂中的一种或若干种提取而得:
丙酮 异丙醇
乙醇 甲醇
二氯乙烷 二氯甲烷
己烷 三氯乙烯
本栏中所指的红辣椒油树脂,仅指用做着色剂者,不同于法规401节中所指的具有法定标准的红辣椒油树脂。
(2)用辣椒油树脂所配制成的食用着色剂混合料,只能选用本分部所列的安全和适用于食品着色的着色剂烯释剂。
(b)质量规格:红辣椒油树脂中所含有的本节(a)(1)中所列的溶剂的残留量,不得超过本章第170至189各部分中列出的允许使用的食品添加剂中香辛料油树脂中所规定的允许溶剂残留量。
(c)使用和限制条件:红辣椒油树脂在符合现行GMP用量条件下,可安全地用于一般食品的着色,但不得用于本法规§401中颁布的已确定标准的食品的着色,除非所加入的色素是这类标准所允许的。
(d)标签标注方式:本着色剂和任何含有本着色剂的混合物,拟单独使用或起部分着色效果时,除法规所规定的其它所需说明以外,其标签还应符合本章§70.25中的规定。
(e)免除产品证书:本着色剂免除产品证书以保护公众健康。所生产的每一批产品也免除按法规§721(c)中所规定的需要产品证书。
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