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§172.836 食品添加剂聚山梨酸酯60(Polysorbate 60)

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放大字体缩小字体2011-04-29 03:43:43 来源:GPO 浏览次数9span id="hits">4220
核心提示:规定了食品添加剂聚山梨酸酯60安全应用于食品中需符合的条件。本添加剂主要用于发泡食用油顶饰料的乳化剂、蛋糕和蛋糕预混合粉中的乳化剂、非标准化糖果的涂层或标准化可可制品的乳化剂、冷食蛋糕糖衣和蛋糕馅料的乳化剂、非透明性的糖蜜饯的涂层、非标准化调味料中的乳化剂、起酥油和食用油的乳化剂、加于酒精饮料中制备混合酒精饮品的非酒精混合料的起泡剂、酵母发酵焙烤制品的面团品质改良剂、生鲜果蔬表面的保护层中作为乳化剂等、/div>
发布单位
FDA
FDA
发布文号 42 FR 14491
发布日期 1977-03-15 生效日期 暂无
有效性状?/th> 废止日期 暂无
备注 规定了食品添加剂聚山梨酸?0安全应用于食品中需符合的条件。本添加剂主要用于发泡食用油顶饰料的乳化剂、蛋糕和蛋糕预混合粉中的乳化剂、非标准化糖果的涂层或标准化可可制品的乳化剂、冷食蛋糕糖衣和蛋糕馅料的乳化剂、非透明性的糖蜜饯的涂层、非标准化调味料中的乳化剂、起酥油和食用油的乳化剂、加于酒精饮料中制备混合酒精饮品的非酒精混合料的起泡剂、酵母发酵焙烤制品的面团品质改良剂、生鲜果蔬表面的保护层中作为乳化剂等、/td>

   172.836 Polysorbate 60.

  The food additive polysorbate 60 (polyoxyethylene ?0 sorbitan monostearate which is a mixture of polyoxyethylene ethers of mixed partial stearic and palmitic acid esters of sorbitol anhydrides and related compounds, may be safely used in food in accordance with the following prescribed conditions:

  (a The food additive is manufactured by reacting stearic acid (usually containing associated fatty acids, chiefly palmitic with sorbitol to yield a product with a maximum acid number of 10 and a maximum water content of 0.2 percent, which is then reacted with ethylene oxide.

  (b The food additive meets the following specifications:

  Saponification number 45C55.

  Acid number 0C2.

  Hydroxyl number 81C96.

  Oxyethylene content 65 percentC69.5 percent.

  (c It is used or intended for use as follows:

  ? As an emulsifier in whipped edible oil topping with or without one or a combination of the following:

  (i Sorbitan monostearate;

  (ii Polysorbate 65;

  (iii Polysorbate 80;

  whereby the maximum amount of the additive or additives used does not exceed 0.4 percent of the weight of the finished whipped edible oil topping; except that a combination of the additive with sorbitan monostearate may be used in excess of 0.4 percent, provided that the amount of the additive does not exceed 0.77 percent and the amount of sorbitan monostearate does not exceed 0.27 percent of the weight of the finished whipped edible oil topping.

  ? As an emulsifier in cakes and cake mixes, with or without one or a combination of the following:

  (i Polysorbate 65.

  (ii Sorbitan monostearate.

  When used alone, the maximum amount of polysorbate 60 shall not exceed 0.46 percent of the cake or cake mix, on a dry-weight basis. When used with polysorbate 65 and/or sorbitan monostearate, it shall not exceed 0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or the sorbitan monostearate exceed 0.61 percent, and no combination of these emulsifiers shall exceed 0.66 percent of the cake or cake mix, all calculated on a dry-weight basis.

  ? As an emulsifier, alone or in combination with sorbitan monostearate, in nonstandardized confectionery coatings and standardized cacao products specified in 163.123, 163.130, 163.135, 163.140, 163.145, and 163.150 of this chapter, as follows:

  (i It is used alone in an amount not to exceed 0.5 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.

  (ii It is used with sorbitan monostearate in any combination of up to 0.5 percent of polysorbate 60 and up to 1 percent of sorbitan monostearate: Provided, That the total combination does not exceed 1 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.

  ? [Reserved]

  ? As an emulsifier in cake icings and cake fillings, with or without one or a combination of the following:

  (i Polysorbate 65.

  (ii Sorbitan monostearate.

  When used alone, the maximum amount of polysorbate 60 shall not exceed 0.46 percent of the weight of the cake icings and cake fillings. When used with polysorbate 65 and/or sorbitan monostearate, it shall not exceed 0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or the sorbitan monostearate exceed 0.7 percent, and no combination of these emulsifiers shall exceed 1 percent of the weight of the cake icing or cake filling.

  ? To impart greater opacity to sugar-type confection coatings whereby the maximum amount of the additive does not exceed 0.2 percent of the weight of the finished sugar coating.

  ? As an emulsifier in nonstandardized dressings whereby the maximum amount of the additive does not exceed 0.3 percent of the weight of the finished dressings.

  ? As an emulsifier, alone or in combination with polysorbate 80, in shortenings and edible oils intended for use in foods as follows, when standards of identity established under section 401 of the act do not preclude such use:

  (i It is used alone in an amount not to exceed 1 percent of the weight of the finished shortening or oil.

  (ii It is used with polysorbate 80 in any combination providing no more than 1 percent of polysorbate 60 and no more than 1 percent of polysorbate 80, provided that the total combination does not exceed 1 percent of the finished shortening or oil.

  (iii The 1Cpercent limitation specified in paragraph (c)(8 (i and (ii of this section may be exceeded in premix concentrates of shortening or edible oil if the labeling complies with the requirements of paragraph (d of this section.

  ? As an emulsifier in solid-state, edible vegetable fat-water emulsions intended for use as substitutes for milk or cream in beverage coffee, with or without one or a combination of the following:

  (i Polysorbate 65.

  (ii Sorbitan monostearate.

  The maximum amount of the additive or additives shall not exceed 0.4 percent by weight of the finished edible vegetable fat-water emulsion.

  ?0 As a foaming agent in nonalcoholic mixes, to be added to alcoholic beverages in the preparation of mixed alcoholic drinks, at a level not to exceed 4.5 percent by weight of the nonalcoholic mix.

  ?1 As a dough conditioner in yeast-leavened bakery products in an amount not to exceed 0.5 percent by weight of the flour used.

  ?2 As an emulsifier, alone or in combination with sorbitan monostearate, in the minimum quantity required to accomplish the intended effect, in formulations of white mineral oil conforming with 172.878 and/or petroleum wax conforming with 172.886 for use as protective coatings on raw fruits and vegetables.

  ?3 As a dispersing agent in artificially sweetened gelatin desserts and in artificially sweetened gelatin dessert mixes, whereby the amount of the additive does not exceed 0.5 percent on a dry-weight basis.

  ?4 As an emulsifier in chocolate flavored syrups, whereby the maximum amount of the additive does not exceed 0.05 percent in the finished product.

  ?5 As a surfactant and wetting agent for natural and artificial colors in food as follows:

  (i In powdered soft drink mixes in an amount not to exceed 4.5 percent by weight of the mix.

  (ii In sugar-based gelatin dessert mixes in an amount not to exceed 0.5 percent by weight of the mix.

  (iii In artificially sweetened gelatin dessert mixes in an amount not to exceed 3.6 percent by weight of the mix.

  (iv In sugar-based pudding mixes in an amount not to exceed 0.5 percent by weight of the mix.

  (v In artificially sweetened pudding mixes in an amount not to exceed 0.5 percent by weight of the mix.

  ?6 As an emulsifier in ice cream, frozen custard, fruit sherbet, and nonstandardized frozen desserts when used alone or in combination with polysorbate 65 and/or polysorbate 80, whereby the maximum amount of the additives, alone or in combination, does not exceed 0.1 percent of the finished frozen dessert.

  (d To assure safe use of the additive, in addition to the other information required by the Act:

  ? The label of the additive and any intermediate premixes shall bear:

  (i The name of the additive.

  (ii A statement of the concentration or strength of the additive in any intermediate premixes.

  ? The label or labeling shall bear adequate directions to provide a final product that complies with the limitations prescribed in paragraph (c of this section.

  [42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, Oct. 28, 1999]

  更多关于美国 FDA 已批准的直接用于人类食品的添加剂种类法规,请点击美国FDA 21 CFR ?72部分已批准的直接用于人类食品的添加剂种类汇怺/a>

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