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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
§ 73.355 Phaffia yeast.
?。╝） Identity. （1） The color additive phaffia yeast consists of the killed, dried cells of a nonpathogenic and nontoxicogenic strain of the yeast Phaffia rhodozyma.
?。?） Phaffia yeast may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with phaffia yeast may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.
?。╞） Specifications. Phaffia yeast shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:
Physical state, solid.
Lead, not more than 5 parts per million.
Arsenic, not more than 2 parts per million.
Mercury, not more than 1 part per million.
Heavy metals （as Pb）, not more than 10 parts per million.
Astaxanthin, not less than 0.4 percent.
（c） Uses and restrictions. Phaffia yeast may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:
?。?） The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.
（2） The quantity of astaxanthin in finished feed, from phaffia yeast when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 milligrams per kilogram （72 grams per ton） of finished feed.
?。╠） Labeling requirements. （1） The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container （established through generally accepted stability testing methods）, other information required by §70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph （c） of this section.
?。?） The presence of the color additive in finished fish feed prepared according to paragraph （c） of this section shall be declared in accordance with §501.4 of this chapter.
?。?） The presence of the color additive in salmonid fish that have been fed feeds containing phaffia yeast shall be declared in accordance with §§101.22（b）, （c）, and （k）（2） and 101.100（a）（2） 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.
[65 FR 41587, July 6, 2000]
§73.355 Phaffia酵母
?。╝）特性：
（1）著色劑Phaffia酵母是由一種非病原性和非毒性名為Phaffia rhodozyma酵母菌株滅活的干燥細(xì)胞組成。
?。?）Phaffia酵母只能作為一種穩(wěn)定著色劑混合物的一種組分用于魚飼料。含Phaffia酵母的用于魚飼料的著色劑混合物，只能選用適當(dāng)?shù)牟⒎媳痉植克械目砂踩赜糜谑秤弥珓┗旌衔锏南♂寗?/p>
（b）質(zhì)量規(guī)格：Phaffia酵母需符合下列質(zhì)量指標(biāo)，除了以下指名的雜質(zhì)在規(guī)定范圍內(nèi)以外，不得含有在GMP條件下可以避免的雜質(zhì)。
物理狀態(tài)，固體。
鉛，不超過5mg/kg。
砷，不超過2mg/kg。
汞，不超過1mg/kg。
重金屬（以鉛計），不超過10mg/kg。
蝦青素，不低于0.4%。
?。╟）使用和限制條件：Phaffia酵母在符合下列限制條件下，可安全地用于鮭類魚飼料：
（1）本著色劑用于使鮭類魚的肉色由粉紅增色至橘紅色。
（2）由單一Phaffia酵母或與其它列于本分部中的蝦青素著色劑混合使用制成的成品飼料中，蝦青素的含量不得超過成品飼料量的80mg/kg（72g/t）。
?。╠）標(biāo)簽標(biāo)注方式：
（1）對密閉和開啟容器本著色劑和所制成的任何預(yù)混料的標(biāo)簽上，應(yīng)標(biāo)明有效期（由通用的可接受的穩(wěn)定性測試方式建立）、本章§70.25要求的其它信息以及符合本部分（c）的限制條件生產(chǎn)最終產(chǎn)品的指導(dǎo)。
?。?）按本部分（c）生產(chǎn)的成品魚飼料，應(yīng)按本章§501.4的要求聲明在鮭類魚中存在本著色劑。
（3）按§101.22（b）、（c）和（K）（2）以及本章101.00（a）（2）的要求，對喂予含有Phaffia酵母的飼料的鮭類魚，應(yīng)聲明含有本著色劑。
?。╡）免除產(chǎn)品證書：本著色劑免除產(chǎn)品證書以保護公眾健康，所生產(chǎn)的每一批產(chǎn)品也免除按法規(guī)§721（c）中所規(guī)定的需要產(chǎn)品證書。
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編輯：foodfagui