§73.355 食品着色剂红发夫酵�?Phaffia yeast)

　　（a� Identity. �?� 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.

　　（b� 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.

　　�?� 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 �?2 grams per ton� of finished feed.

　　（d� Labeling requirements. �?� 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

　　（a）特性：

　　�?）着色剂Phaffia酵母是由一种非病原性和非毒性名为Phaffia rhodozyma酵母菌株灭活的干燥细胞组成、�/p>

　　�?）Phaffia酵母只能作为一种稳定着色剂混合物的一种组分用于鱼饲料。含Phaffia酵母的用于鱼饲料的着色剂混合物，只能选用适当的并符合本分部所列的可安全地用于食用着色剂混合物的稀释剂、�/p>

　　（b）质量规格：Phaffia酵母需符合下列质量指标，除了以下指名的杂质在规定范围内以外，不得含有在GMP条件下可以避免的杂质、�/p>

　　物理状态，固体、�/p>

　　铅，不超�?mg/kg、�/p>

　　砷，不超�?mg/kg、�/p>

　　汞，不超�?mg/kg、�/p>

　　重金属（以铅计），不超过10mg/kg、�/p>

　　虾青素，不低�?.4%、�/p>

　　（c）使用和限制条件：Phaffia酵母在符合下列限制条件下，可安全地用于鲑类鱼饲料９�/p>

　　�?）本着色剂用于使鲑类鱼的肉色由粉红增色至橘红色、�/p>

　　�?）由单一Phaffia酵母或与其它列于本分部中的虾青素着色剂混合使用制成的成品饲料中，虾青素的含量不得超过成品饲料量�?0mg/kg�?2g/t）、�/p>

　　（d）标签标注方式：

　　�?）对密闭和开启容器本着色剂和所制成的任何预混料的标签上，应标明有效期（由通用的可接受的稳定性测试方式建立）、本�?sect;70.25要求的其它信息以及符合本部分（c）的限制条件生产最终产品的指导、�/p>

　　�?）按本部分（c）生产的成品鱼饲料，应按本章��501.4的要求声明在鲑类鱼中存在本着色剂、�/p>

　　�?）按��101.22（b）、（c）和（K）（2）以及本�?01.00（a）（2）的要求，对喂予含有Phaffia酵母的饲料的鲑类鱼，应声明含有本着色剂、�/p>

　　（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�?sect;721（c）中所规定的需要产品证书、�br />