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§73.185 食品着色剂红球藻属海藻粉(Haematococcus algae meal)

   日期:2011-07-30     来源:中国食品网    作者:中食网    浏览:1014    

  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

  § 73.185   Haematococcus algae meal.

  (a) Identity. (1) The color additive haematococcus algae meal consists of the comminuted and dried cells of the alga Haematococcus pluvialis.

  (2) Haematococcus algae meal 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 haematococcus algae meal 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. Haematococcus algae meal 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 1.5 percent.

  (c) Uses and restrictions. Haematococcus algae meal may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:

  (1) 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 haematococcus algae meal 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.

  (d) 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.

  (2) 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.

  (3) The presence of the color additive in salmonid fish that have been fed feeds containing haematococcus algae meal 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 41584, July 6, 2000]

  §73.185 红球藻属海藻粉

  (a)特性:

  (1)着色剂红球藻属海藻粉,是由细碎和干的Haematococcus pluvialis藻细胞组成。

  (2)着色剂红球藻属海藻粉仅作为一种稳定着色剂混合物的一种组分用于鱼饲料,用于鱼饲料的这种着色剂混合料只能选用合适的本分部所列的可安全地用于食品着色的着色剂混合物稀释剂。

  (b)质量规格:红球藻属海藻粉需符合下列质量指标,所含杂质只能是在GMP条件下不可避免的。

  物理状态,固态。

  铅,不超过5mg/kg。

  砷,不超过2mg/kg。

  汞,不超过1mg/kg。

  重金属(以铅计),不超过10mg/kg。

  虾青素,不低于1.5%。

  (c)使用和限制条件:红球藻属海藻粉在符合下列限制条件下安全地用于鲑鱼类饲料:

  (1)本着色剂用于将鲑鱼类肉色由粉红色增色至橘红色。

  (2)由单一红球藻属海藻粉或其它列于本法规73部分的虾青素着色剂混合使用制成的饲料成品中,虾青素的含量在最终饲料成品中不可超过80mg/kg(72g/t)。

  (d)标签标注方式:

  (1)对封闭和开启容器的着色剂和任何预混料标签上,应注明有效期(由通用的可接受的稳定性测试方式建立)、本章§70.25要求的其它信息以及符合本部分(c)的限制条件生产最终产品的指导。

  (2)按本部分(c)的规定生产的成品鱼饲料,应按本章§501.4的要求声明含有本着色剂。

  (3)按§101.22(b)、(c)和(k)(2)以及本章101.100(a)(2)的要求,喂饲含有红球藻属海藻粉饲料的鲑鱼类,应声明鱼中存在着色剂。

  (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规§721(c)中所规定的需要产品证书。
 

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