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§73.35 食品著色劑蝦青素(Astaxanthin)

   2011-07-30 780
核心提示:  原文后附帶中文翻譯,由食品伙伴網食品論壇網友gaoketian提供,食品伙伴網在此表示感謝! 更多關于美國 FDA 21 CFR 第 73 部

  原文后附帶中文翻譯,由食品伙伴網食品論壇網友gaoketian提供,食品伙伴網在此表示感謝!

    更多關于美國 FDA 21 CFR 第 73 部分的內容,請詳見美國FDA 21 CFR 第73部分關于免除產品證書的食品用著色劑種類匯總

  § 73.35   Astaxanthin.

 ?。╝) Identity. (1) The color additive astaxanthin is 3, 3′-dihydroxy-β, β-carotene-4, 4′-dione.

 ?。?) Astaxanthin 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 astaxanthin 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. Astaxanthin 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.

  0.05 percent solution in chloroform, complete and clear.

  Absorption maximum wavelength 484–493 nanometers (in chloroform).

  Residue on ignition, not more than 0.1 percent.

  Total carotenoids other than astaxanthin, not more than 4 percent.

  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, not more than 10 parts per million.

  Assay, minimum 96 percent.

  (c) Uses and restrictions. Astaxanthin 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 color additive in feed is such that the color additive 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 astaxanthin shall be declared in accordance with §§101.22(k)(2) and 101.100(a)(2) of this chapter.

 ?。╡) 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.

  [60 FR 18738, Apr. 13, 1995]

  §73.35 蝦青素

 ?。╝)特性:

 ?。?)著色劑蝦青素的化學名為3,3'-二羥基-β,β-胡蘿卜素-4,4'-二酮。

 ?。?)蝦青素僅作為一種穩定的著色劑混合料的組成之一用于魚飼料中。供魚飼料用的加有蝦青素的著色劑混合料,只能選用適當的和符合本分部中所列可安全地用于食品著色的稀釋劑。

  (b)質量規格:蝦青素應符合下列質量規格,除了指名的雜質在規定范圍內以外,不得含有在現行GMP條件下可以避免的雜質:

  物理狀態為固體。

  0. 05%的氯仿溶液應全部溶解并澄清。

  最大吸收波長為484~493nm(于氯仿中)。

  灼燒殘渣,不超過0.1%。

  蝦青素以外的總類胡蘿卜素,不超過4%。

  鉛,不超過5mg/kg。

  砷,不超過2mg/kg。

  汞,不超過1mg/kg。

  重金屬,不超過10mg/kg。

  含量,不低于96%。

  (c)使用和限制條件:蝦青素在符合下列條件下,可安全地用于鮭魚類的飼料。

 ?。?)本著色劑是用于加深鮭魚類的肉色由粉紅至橙紅色。

 ?。?)本著色劑在飼料中的用量,不得超過成品飼料量的80mg/kg(72g/t)。

 ?。╠)標簽標注方式:

 ?。?)本著色劑和任何由本著色劑配成的混合料,無論是密封包裝的或是用敞口容器盛裝的,均須標明失效期(須由一般公認的穩定性試驗法確定),此外,其標簽尚應符合本章§70.25中的要求,對本節(c)中所述的限制條件也應做充分說明,以使最終成品符合條件。

 ?。?)根據本節(c)中要求生產的含有蝦青素的成品魚飼料,應按本章§501.4要求標明含有蝦青素。

 ?。?)含有蝦青素的喂飼鮭魚類的飼料,應按照本章§101.22(k)(2)和§101.100(a)(2)中的要求標明含有蝦青素。

 ?。╡)免除產品證書:本著色劑免除產品證書以保護公眾健康。所生產的每批產品也免除按法規721(c)中規定的需要產品證書。
 



 
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