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        更多關(guān)于美國(guó) FDA 21 CFR 第 73 部分的內(nèi)容，請(qǐng)?jiān)斠?jiàn)美國(guó)FDA 21 CFR 第73部分關(guān)于免除產(chǎn)品證書(shū)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.

　　（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.

　?。?） 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).

　　（b） Special use —（1） Diluents in color additive mixtures for marking food —（i） Inks for marking food supplements in tablet form, gum, and confectionery. Items listed in paragraph （a） of this section and the following:

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

　?。╥i） Inks for marking fruit and vegetables. Items listed in paragraph （a） of this section and the following:

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

　　（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）.

　?。?） 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(shū)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(wú)需證書(shū)，但必須明確混合物中每種著色劑為免除證書(shū)的條件，或者，如果不是免除證書(shū)的，也應(yīng)是以前已檢測(cè)過(guò)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(guò)，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)。

　?。?）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。

　　（3）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(jiàn)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(guò)1%(以無(wú)水乙二胺四乙酸二鈉鈣計(jì))
蓖麻油	見(jiàn)美國(guó)藥典第16版中規(guī)定所列	在食品成品中不得超過(guò)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(shuō)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	見(jiàn)本章§172、810中規(guī)定所列	在食品成品中不得超過(guò)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(shuō)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(jiàn)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(guò)1%(以無(wú)水乙二胺四乙酸二鈉計(jì))

　?。╞）特殊用途：

　　（1）食品標(biāo)記用著色劑混合物的稀釋劑

　?。╥）片狀營(yíng)養(yǎng)增補(bǔ)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(jiàn)26美國(guó)聯(lián)邦法規(guī)212部分	無(wú)殘留
正丁醇		無(wú)殘留
十六醇	見(jiàn)美國(guó)配方集第11版	無(wú)殘留
環(huán)己烷	—	無(wú)殘留
乙基纖維素	見(jiàn)本章§172、868	無(wú)殘留
乙二醇單乙酯	—	無(wú)殘留
異丁醇	—	無(wú)殘留
異丙醇	—	無(wú)殘留
聚氧乙烯脫水山梨醇單油酸酯(聚山梨酸酯80)	見(jiàn)本章§172、840
聚醋酸乙烯酯	相對(duì)分子質(zhì)量最低2000
聚乙烯吡咯烷酮見(jiàn)本章§173、55
松香及松香衍生物見(jiàn)本章§172、615
精制蟲(chóng)膠	食用級(jí)

　　§73.1（ii）水果、蔬菜的標(biāo)記用墨水。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
丙酮	見(jiàn)(美國(guó))《國(guó)家配方集》第11版	無(wú)殘留
醇，SDA-3A	見(jiàn)26美國(guó)聯(lián)邦法規(guī)212部分	無(wú)殘留
安息香	見(jiàn)《美國(guó)藥典》第16版
馬尼拉產(chǎn)的樹(shù)脂
乙酸乙酯	見(jiàn)(美國(guó))《國(guó)家配方集》第11版	無(wú)殘留
乙基纖維素	見(jiàn)本章§172、868
二氯甲烷	—	無(wú)殘留
聚乙烯吡咯烷酮	見(jiàn)本章§173、55
松香及其衍生物	見(jiàn)本章§172、615
二氧化硅	見(jiàn)本章§172、480	不超過(guò)墨水固形物含量的2%
天然萜烯樹(shù)脂	見(jiàn)本章§172、615
合成萜烯樹(shù)脂	α-和β-蒎烯的聚合物

　?。?）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(huì)經(jīng)蛋殼滲透進(jìn)入蛋中：

　　變性酒精，配方23A（26美國(guó)聯(lián)邦法規(guī)212部分），國(guó)際稅務(wù)署

　　達(dá)馬膠（達(dá)馬樹(shù)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）

　　（c）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(jiàn)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(guò)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(shuō)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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