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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
§ 73.295 Tagetes (Aztec marigold) meal and extract.
(a) Identity. (1) The color additive tagetes (Aztec marigold) meal is the dried, ground flower petals of the Aztec marigold ( Tagetes erecta L.) mixed with not more than 0.3 percent ethoxyquin.
(2) The color additive tagetes (Aztec marigold) extract is a hexane extract of the flower petals of the Aztec marigold ( Tagetes erecta L.). It is mixed with an edible vegetable oil, or with an edible vegetable oil and a hydrogenated edible vegetable oil, and not more than 0.3 percent ethoxyquin. It may also be mixed with soy flour or corn meal as a carrier.
(b) Specifications. (1) Tagetes (Aztec marigold) meal is free from admixture with other plant material from Tageteserecta L. or from plant material or flowers of any other species of plants.
(2) Tagetes (Aztec marigold) extract shall be prepared from tagetes (Aztec marigold) petals meeting the specifications set forth in paragraph (b)(1) of this section and shall conform to the following additional specifications:
Melting point | 53.5–55.0 °C. |
Iodine value | 132–145. |
Saponification value | 175–200. |
Acid value | 0.60–1.20. |
Titer | 35.5°–37.0 °C. |
Unsaponifiable matter | 23.0 percent–27.0 percent. |
Hexane residue | Not more than 25 p.p.m. |
All determinations, except the hexane residue, shall be made on the initial extract of the flower petals (after drying in a vacuum oven at 60 °C. for 24 hours) prior to the addition of the oils and ethoxyquin. The hexane determination shall be made on the color additive after the addition of the vegetable oils, hydrogenated vegetable oils, and ethoxyquin.
(c) Uses and restrictions. The color additives tagetes (Aztec marigold) meal and extract may be safely used in chicken feed in accordance with the following prescribed conditions:
(1) The color additives are used to enhance the yellow color of chicken skin and eggs.
(2) The quantity of the color additives incorporated in the feed is such that the finished feed:
(i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (c)(1) of this section; and
(ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in §573.380 of this chapter.
(d) Labeling requirements. The label of the color additives and any premixes prepared therefrom shall bear, in addition to the information required by §70.25 of this chapter:
(1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein.
(2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (c) of this section.
(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.
§73.295 万寿菊粉和提取物
(a)特性:
(1)着色剂万寿菊粉,系万寿菊(Tagetes erecta L.)干燥并磨碎的花瓣与含量不超过0.3%乙氧基喹的混合物。
(2)着色剂万寿菊提取物系万寿菊(Tagetes erecta L.)花瓣的己烷提取物,与食用植物油或食用植物油加上氢化食用植物油,以及不超过0.3%的乙氧基喹混合的混合物。它也可以混入作为载体的大豆粉或玉米粉。
(b)质量规格:
(1)万寿菊粉中不得掺有万寿菊的其它植株部分,也不得掺有任何其它种类植物的植株部分或花。
(2)万寿菊提取物必须由符合本节(b)(1)质量规格的万寿菊花瓣制成,并须符合下述附加的质量指标:
熔点,53.5~55.0℃。
碘值,132~145。
皂化值,175~200。
酸值,0.60~1.20。
冻点,35.5~37.0℃。
不皂化物,23.0%~27.0%。
残留己烷,不超过25mg/kg。
所有的指标测定,除己烷残留量外,均须在加入油和乙氧基喹之前,将花瓣放在真空烘箱中,于60℃干燥24h后,进行初馏物的提取。己烷的测定,则需在加入植物油、氢化植物油和乙氧基喹之后的着色剂上进行。
(c)使用和限制条件:着色剂万寿菊粉和提取物可安全地用于鸡饲料,但应符合下列规定的条件:
(1)本着色剂用做加深鸡皮和鸡蛋的黄色。
(2)这种着色剂在饲料中的用量,应使饲料成品能达到:
(i)作为叶黄素和类胡萝卜素的增补料,能达到本节(c)(1)中规定的效果,并且:
(ii)乙氧基喹在动物饲料中的用量,应符合本章§573.380中所规定的容许使用限量。
(d)标签标注方式:本着色剂和任何混有本着色剂的预混合物,其标签除本章§70.25中所需标明的资料外,还应标明:
(1)其中所含叶黄素和乙氧基喹的浓度情况说明。
(2)详细的使用说明,以保证成品能完全符合本章(b)中所规定的限制条件。
(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)中所规定需要产品证书。