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更多關(guān)于美國 FDA 21 CFR 第 73 部分的內(nèi)容，請詳見美國FDA 21 CFR 第73部分關(guān)于免除產(chǎn)品證書的食品用著色劑種類匯總
§ 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.
?。╝） General use. （1） Substances that are generally recognized as safe under the conditions set forth in section 201（s） of the act.
?。?） Substances meeting the definitions and specifications set forth under subchapter B of this chapter, and which are used only as prescribed by such regulations.
?。?） 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. 172.810 of 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. 172.840 of 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. 172.868 of this chapter | |
| Methylene chloride | ||
| 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 | |
| Silicon dioxide | As set forth in sec. 172.480 of this chapter | Not more than 2 pct of the ink solids. |
| Terpene resins, natural | As set forth in sec. 172.615 of this chapter | |
| Terpene resins, synthetic | Polymers of α- and β-pinene |
?。?） 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）.
?。?） 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. 173.55 of 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 免除產(chǎn)品證書的食品用著色劑混合物中的稀釋劑
以下各物質(zhì)可安全地用做食品用著色劑混合物中的稀釋劑而無需證書，但必須明確混合物中每種著色劑為免除證書的條件，或者，如果不是免除證書的，也應(yīng)是以前已檢測過的一批料，并且自以前發(fā)證后其組成并未改變的。如某種特殊稀釋劑的規(guī)格并未在本部分中提出過，則其純度必須與其使用所要求的相符。
?。╝）普通用途：
?。?）在法規(guī)201（S）中所述的條件下，一般公認(rèn)為安全的一些物質(zhì)。
（2）符合本章B分部中所規(guī)定的定義和規(guī)格的一些物質(zhì)，并僅限用于該規(guī)定中所述的使用范圍。
?。?）下列各物質(zhì)：
|
物質(zhì)名稱 |
定義和規(guī)格 |
限 制 條 件 |
|
EDTA二鈉鈣(乙二胺四乙酸二鈉鈣) |
含乙二胺四乙酸二鈉鈣二水物(CAS No. 6766-87-6),見FCC-Ⅲ(1981),P.50所列 |
僅用于由口腔攝入的著色劑混合物中，可作為防腐劑和螯合劑用于水溶液和水分散液中；著色劑混合物(溶液或分散液)中可含有稀釋劑的量應(yīng)不超過1%(以無水乙二胺四乙酸二鈉鈣計) |
|
蓖麻油 |
見美國藥典第16版中規(guī)定所列 |
在食品成品中不得超過500mg/kg。含有蓖麻油的著色劑混合物，其標(biāo)簽上必須標(biāo)明適當(dāng)?shù)氖褂谜f明，以使其在食品中的用量符合本欄的限制規(guī)定 |
|
磺基丁二酸二辛基鈉鹽 |
在食品成品中不得超過9mg/kg。含有磺基丁二酸二辛基鈉鹽的著色劑混合物，其標(biāo)簽上必須標(biāo)明適當(dāng)?shù)氖褂谜f明，以使其在食品中的用量符合本欄的限制規(guī)定 |
|
|
EDTA二鈉(乙二胺四乙酸二鈉) |
含乙二胺四乙酸二鈉二水物(CAS No.6381-92-6),見FCC-Ⅲ(1981)，P.104所列 |
僅用于由口腔攝入的著色劑混合物中，可作為防腐劑和螯合劑用于水溶液和水分散液中。著色劑混合物(溶液或分散液)中可含有稀釋劑的量應(yīng)不超過1%(以無水乙二胺四乙酸二鈉計) |
?。╞）特殊用途：
?。?）食品標(biāo)記用著色劑混合物的稀釋劑
?。╥）片狀營養(yǎng)增補劑、膠姆糖和糖果類食品的標(biāo)記用墨水?？捎梦镔|(zhì)如本節(jié)（a）中所列，以及下述各物質(zhì)：
|
物 質(zhì) 名 稱 |
定義和規(guī)格 |
限制條件 |
|
醇，SDA-3A |
見26美國聯(lián)邦法規(guī)212部分 |
無殘留 |
|
正丁醇 |
無殘留 |
|
|
十六醇 |
見美國配方集第11版 |
無殘留 |
|
環(huán)己烷 |
— |
無殘留 |
|
乙基纖維素 |
見本章§172、868 |
無殘留 |
|
乙二醇單乙酯 |
— |
無殘留 |
|
異丁醇 |
— |
無殘留 |
|
異丙醇 |
— |
無殘留 |
|
聚氧乙烯脫水山梨醇單油酸酯(聚山梨酸酯80) |
見本章§172、840 |
|
|
聚醋酸乙烯酯 |
相對分子質(zhì)量最低2000 |
|
|
聚乙烯吡咯烷酮見本章§173、55 |
||
|
松香及松香衍生物見本章§172、615 |
||
|
精制蟲膠 |
食用級 |
§73.1（ii）水果、蔬菜的標(biāo)記用墨水?？捎梦镔|(zhì)如本節(jié)（a）中所列，以及下述各物質(zhì)：
|
物 質(zhì) 名 稱 |
定義和規(guī)格 |
限 制 條 件 |
|
丙酮 |
見(美國)《國家配方集》第11版 |
無殘留 |
|
醇，SDA-3A |
見26美國聯(lián)邦法規(guī)212部分 |
無殘留 |
|
安息香 |
見《美國藥典》第16版 |
|
|
馬尼拉產(chǎn)的樹脂 |
||
|
乙酸乙酯 |
見(美國)《國家配方集》第11版 |
無殘留 |
|
乙基纖維素 |
見本章§172、868 |
|
|
二氯甲烷 |
— |
無殘留 |
|
聚乙烯吡咯烷酮 |
見本章§173、55 |
|
|
松香及其衍生物 |
見本章§172、615 |
|
|
二氧化硅 |
見本章§172、480 |
不超過墨水固形物含量的2% |
|
天然萜烯樹脂 |
見本章§172、615 |
|
|
合成萜烯樹脂 |
α-和β-蒎烯的聚合物 |
（2）帶殼蛋著色用著色劑混合物中的稀釋劑可用物質(zhì)如本節(jié)（a）中所列，以及下述各物質(zhì)，并且著色劑混合物或其中含有的任何成分應(yīng)不會經(jīng)蛋殼滲透進入蛋中：
變性酒精，配方23A（26美國聯(lián)邦法規(guī)212部分），國際稅務(wù)署
達馬膠（達馬樹脂）
二硬脂酸二丙二醇酯
磺基丁二酸二辛基鈉鹽
乙基纖維素（與本章§172、820中規(guī)定相一致）
二硬脂酸丙二醇酯
日本蠟
石灰松香
石腦油
富馬酸季戊四醇酯與松香的加成物
聚乙二醇6000（與本章§172、820中的規(guī)定相一致）
聚乙烯醇
松香和松香衍生物（與本章§172.615中的規(guī)定相一致）
?。╟）其它特殊用途：可用物質(zhì)如本節(jié)（a）中所列，以及下述各物質(zhì)：
|
物 質(zhì) 名 稱 |
定義和規(guī)格 |
限 制 條 件 |
|
聚乙烯吡咯烷酮 |
見本章§173、55 |
用于片狀食品或其涂層料；在食品成品中的用量不得超過0.1%；在含有聚乙烯吡咯烷酮的著色劑混合料的標(biāo)簽上，應(yīng)標(biāo)明適當(dāng)?shù)氖褂谜f明，以使其在食品中的用量符合本欄的限制規(guī)定 |
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