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更多关于美国 FDA 21 CFR 73 部分的内容,请详?a href="//www.sqrdapp.com/law/show-172305.html">美国FDA 21 CFR ?3部分关于免除产品证书的食品用着色剂种类汇怺/font>
73.575 Titanium dioxide.
(a Identity. ? The color additive titanium dioxide is synthetically prepared TiO2, free from admixture with other substances.
? Color additive mixtures for food use made with titanium dioxide may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods, and the following: Silicon dioxide, SiO2and/or aluminum oxide, Al2O3, as dispersing aidsnot more than 2 percent total.
(b Specifications. Titanium dioxide shall conform to the following specifications:
Lead (as Pb? not more than 10 parts per million.
Arsenic (as As? not more than 1 part per million.
Antimony (as Sb? not more than 2 parts per million.
Mercury (as Hg? not more than 1 part per million.
Loss on ignition at 800 C. (after drying for 3 hours at 105 C.? not more than 0.5 percent.
Water soluble substances, not more than 0.3 percent.
Acid soluble substances, not more than 0.5 percent.
TiO2, not less than 99.0 percent after drying for 3 hours at 105 C.
Lead, arsenic, and antimony shall be determined in the solution obtained by boiling 10 grams of the titanium dioxide for 15 minutes in 50 milliliters of 0.5 N hydrochloric acid.
(c Uses and restrictions. The color additive titanium dioxide may be safely used for coloring foods generally, subject to the following restrictions:
? The quantity of titanium dioxide does not exceed 1 percent by weight of the food.
? It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
(d Labeling. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of 70.25 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.
73.575 二氧化钛
(a)特性:
?)着色剂二氧化钛系合成所得的TiO2,不得掺有其它物质、/p>
?)用二氧化钛配制成的食用着色剂混合料,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,以及下列作为分散剂的各物质:二氧化硅(SiO2)和?或氧化铝(Al2O3),但它们的用量不得超过总量?%、/p>
(b)质量规格:二氧化钛需符合下列质量指标9/p>
铅(以Pb计),不超过10mg/kg、/p>
砷(以As计),不超过1mg/kg、/p>
锑(以Sb计),不超过2mg/kg、/p>
汞(以Hg计),不超过1mg/kg、/p>
灼烧失重?05℃干?h后,800℃灼烧),不超过0.5%、/p>
水溶性物质,不超?.3%、/p>
酸溶性物质,不超?.5%、/p>
TiO2?05℃干?h后,不低?9.0%、/p>
铅、砷和锑的测定:取二氧化?0g,加0.5mol/L盐酸50mL,煮?5min后将所得的溶液进行测定、/p>
(c)使用和限制条件:着色剂二氧化钛可安全地用于一般食品的着色,但应符合下列限制条件9/p>
?)二氧化钛的用量不得超过食品量的1%、/p>
?)不得用于本法规401中所颁布的已确定标准的食品的着色,除非所加入的色素是这类标准所允许的、/p>
(d)标签标注方式:本着色剂和任何含有本着色剂的混合物,拟单独使用或起部分着色效果时,除法规所规定的其它所需说明以外,其标签尚应符合本章70.25中的规定、/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,所生产的每批产品也免除按法?sect;721(c)中规定的需要产品证书、br />