原文后附带中文翻译，由食品伙伴网食品论坛网友gaoketian提供，食品伙伴网在此表示感谢！
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
§ 73.1 Diluents in color additive mixtures for food use exempt from certification.
The following substances may be safely used as diluents in color additive mixtures for food use exempt from certification, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. If a specification for a particular diluent is not set forth in this part 73, the material shall be of a purity consistent with its intended use.
（a） General use. （1） Substances that are generally recognized as safe under the conditions set forth in section 201（s） of the act.
（2） Substances meeting the definitions and specifications set forth under subchapter B of this chapter, and which are used only as prescribed by such regulations.
（3） The following:
| Substances | Definitions and specifications | Restrictions |
| Calcium disodium EDTA (calcium disodium ethyl- enediamine- tetraacetate) | Contains calcium disodium ethyl- enediamine- tetraacetate dihydrate (CAS Reg. No. 6766–87–6) as set forth in the Food Chemicals Codex, 3d ed., p. 50, 1981 | May be used in aqueous solutions and aqueous dispersions as a preservative and sequestrant in color additive mixtures intended only for ingested use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous calcium disodium ethyl-enediamine-tetraacetate). |
| Castor oil | As set forth in U.S.P. XVI | Not more than 500 p.p.m. in the finished food. Labeling of color additive mixtures containing castor oil shall bear adequate directions for use that will result in a food meeting this restriction. |
| Dioctylsodium sulfosuccinate | As set forth in sec.172.810of this chapter | Not more than 9 p.p.m. in the finished food. Labeling of color additive mixtures containing dioctylsodium sulfosuccinate shall bear adequate directions for use that will result in a food meeting this restriction. |
| Disodium EDTA (disodium ethyl- enediamine- tetraacetate) | Contains disodium ethyl- enediamine- tetraacetate dihydrate (CAS Reg. No. 6381–92–6) as set forth in the Food Chemicals Codex, 3d ed., p. 104, 1981 | May be used in aqueous solutions and aqueous dispersions as a preservative and sequestrant in color additive mixtures intended only for ingested use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous disodium ethyl- enediamine- tetraacetate). |
| Substances | Definitions and specifications | Restrictions |
| Alcohol, SDA–3A | As set forth in 26 CFR pt. 212 | No residue. |
| n-Butyl alcohol | Do. | |
| Cetyl alcohol | As set forth in N.F. XI | Do. |
| Cyclohexane | Do. | |
| Ethyl cellulose | As set forth in sec. 172.868 of this chapter | |
| Ethylene glycol monoethyl ether | Do. | |
| Isobutyl alcohol | Do. | |
| Isopropyl alcohol | Do. | |
| Polyoxyethylene sorbitan monooleate (polysorbate 80) | As set forth in sec.172.840of this chapter | |
| Polyvinyl acetate | Molecular weight, minimum 2,000 | |
| Polyvinylpyrrolidone | As set forth in sec. 173.55 of this chapter | |
| Rosin and rosin derivatives | As set forth in sec. 172.615 of this chapter | |
| Shellac, purified | Food grade |
| Substances | Definitions and specifications | Restrictions |
| Acetone | As set forth in N.F. XI | No residue. |
| Alcohol, SDA–3A | As set forth in 26 CFR pt. 212 | Do. |
| Benzoin | As set forth in U.S.P. XVI | |
| Copal, Manila | ||
| Ethyl acetate | As set forth in N.F. XI | Do. |
| Ethyl cellulose | As set forth in sec.172.868of this chapter | |
| Methylene chloride | ||
| Polyvinylpyrrolidone | As set forth in sec.173.55of this chapter | |
| Rosin and rosin derivatives | As set forth in sec.172.615of this chapter | |
| Silicon dioxide | As set forth in sec.172.480of this chapter | Not more than 2 pct of the ink solids. |
| Terpene resins, natural | As set forth in sec.172.615of this chapter | |
| Terpene resins, synthetic | Polymers of α- and β-pinene |
（2） Diluents in color additive mixtures for coloring shell eggs. Items listed in paragraph （a） of this section and the following, subject to the condition that there is no penetration of the color additive mixture or any of its components through the eggshell into the egg:
Alcohol, denatured, formula 23A （26 CFR part 212）, Internal Revenue Service.
Damar gum （resin）.
Diethylene glycol distearate.
Dioctyl sodium sulfosuccinate.
Ethyl cellulose （as identified in §172.868 of this chapter）.
Ethylene glycol distearate.
Japan wax.
Limed rosin.
Naphtha.
Pentaerythritol ester of fumaric acid-rosin adduct.
Polyethylene glycol 6000 （as identified in §172.820 of this chapter）.
Polyvinyl alcohol.
Rosin and rosin derivatives （as identified in §172.615 of this chapter）.
（3） Miscellaneous special uses. Items listed in paragraph （a） of this section and the following:
| Substances | Definitions and specifications | Restrictions |
| Polyvinylpyrrolidone | As set forth in sec.173.55of this chapter | In or as food-tablet coatings; limit, not more than 0.1 pct in the finished food; labeling of color additive mixtures containing polyvinylpyrrolidone shall bear adequate directions for use that will result in a food meeting this restriction. |
[42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992; 69 FR 24511, May 4, 2004]
§73.1 免除产品证书的食品用着色剂混合物中的稀释剂
以下各物质可安全地用做食品用着色剂混合物中的稀释剂而无需证书，但必须明确混合物中每种着色剂为免除证书的条件，或者，如果不是免除证书的，也应是以前已检测过的一批料，并且自以前发证后其组成并未改变的。如某种特殊稀释剂的规格并未在本部分中提出过，则其纯度必须与其使用所要求的相符。
（a）普通用途：
（1）在法规201（S）中所述的条件下，一般公认为安全的一些物质。
（2）符合本章B分部中所规定的定义和规格的一些物质，并仅限用于该规定中所述的使用范围。
（3）下列各物质：
物质名称 |
定义和规格 |
限 制 条 件 |
EDTA二钠钙(乙二胺四乙酸二钠钙) |
含乙二胺四乙酸二钠钙二水物(CAS No. 6766-87-6),见FCC-Ⅲ(1981),P.50所列 |
仅用于由口腔摄入的着色剂混合物中，可作为防腐剂和螯合剂用于水溶液和水分散液中；着色剂混合物(溶液或分散液)中可含有稀释剂的量应不超过1%(以无水乙二胺四乙酸二钠钙计) |
蓖麻油 |
见美国药典第16版中规定所列 |
在食品成品中不得超过500mg/kg。含有蓖麻油的着色剂混合物，其标签上必须标明适当的使用说明，以使其在食品中的用量符合本栏的限制规定 |
磺基丁二酸二辛基钠盐 |
在食品成品中不得超过9mg/kg。含有磺基丁二酸二辛基钠盐的着色剂混合物，其标签上必须标明适当的使用说明，以使其在食品中的用量符合本栏的限制规定 |
|
EDTA二钠(乙二胺四乙酸二钠) |
含乙二胺四乙酸二钠二水物(CAS No.6381-92-6),见FCC-Ⅲ(1981)，P.104所列 |
仅用于由口腔摄入的着色剂混合物中，可作为防腐剂和螯合剂用于水溶液和水分散液中。着色剂混合物(溶液或分散液)中可含有稀释剂的量应不超过1%(以无水乙二胺四乙酸二钠计) |
（b）特殊用途：
（1）食品标记用着色剂混合物的稀释剂
（i）片状营养增补剂、胶姆糖和糖果类食品的标记用墨水。可用物质如本节（a）中所列，以及下述各物质：
物 质 名 称 |
定义和规格 |
限制条件 |
醇，SDA-3A |
见26美国联邦法规212部分 |
无残留 |
正丁醇 |
无残留 |
|
十六醇 |
见美国配方集第11版 |
无残留 |
环己烷 |
— |
无残留 |
乙基纤维素 |
见本章§172、868 |
无残留 |
乙二醇单乙酯 |
— |
无残留 |
异丁醇 |
— |
无残留 |
异丙醇 |
— |
无残留 |
聚氧乙烯脱水山梨醇单油酸酯(聚山梨酸酯80) |
见本章§172、840 |
|
聚醋酸乙烯酯 |
相对分子质量最低2000 |
|
聚乙烯吡咯烷酮见本章§173、55 |
||
松香及松香衍生物见本章§172、615 |
||
精制虫胶 |
食用级 |
§73.1（ii）水果、蔬菜的标记用墨水。可用物质如本节（a）中所列，以及下述各物质：
物 质 名 称 |
定义和规格 |
限 制 条 件 |
丙酮 |
见(美国)《国家配方集》第11版 |
无残留 |
醇，SDA-3A |
见26美国联邦法规212部分 |
无残留 |
安息香 |
见《美国药典》第16版 |
|
马尼拉产的树脂 |
||
乙酸乙酯 |
见(美国)《国家配方集》第11版 |
无残留 |
乙基纤维素 |
见本章§172、868 |
|
二氯甲烷 |
— |
无残留 |
聚乙烯吡咯烷酮 |
见本章§173、55 |
|
松香及其衍生物 |
见本章§172、615 |
|
二氧化硅 |
见本章§172、480 |
不超过墨水固形物含量的2% |
天然萜烯树脂 |
见本章§172、615 |
|
合成萜烯树脂 |
α-和β-蒎烯的聚合物 |
（2）带壳蛋着色用着色剂混合物中的稀释剂可用物质如本节（a）中所列，以及下述各物质，并且着色剂混合物或其中含有的任何成分应不会经蛋壳渗透进入蛋中：
变性酒精，配方23A（26美国联邦法规212部分），国际税务署
达马胶（达马树脂）
二硬脂酸二丙二醇酯
磺基丁二酸二辛基钠盐
乙基纤维素（与本章§172、820中规定相一致）
二硬脂酸丙二醇酯
日本蜡
石灰松香
石脑油
富马酸季戊四醇酯与松香的加成物
聚乙二醇6000（与本章§172、820中的规定相一致）
聚乙烯醇
松香和松香衍生物（与本章§172.615中的规定相一致）
（c）其它特殊用途：可用物质如本节（a）中所列，以及下述各物质：
物 质 名 称 |
定义和规格 |
限 制 条 件 |
聚乙烯吡咯烷酮 |
见本章§173、55 |
用于片状食品或其涂层料；在食品成品中的用量不得超过0.1%；在含有聚乙烯吡咯烷酮的着色剂混合料的标签上，应标明适当的使用说明，以使其在食品中的用量符合本栏的限制规定 |
更多国外法规翻译，请联系食品翻译中心
编辑：foodfagui