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§173.357 用于酶制剂固定的固定剂(Materials used as fixing agents in the immobilization of enzyme preparations)

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核心提示: 可安全用于酶制剂固定的固定剂物质包括:丙烯酰胺丙烯酸树脂,可用做葡萄糖异构酶制剂(符合本章§184.1372 要求)的固定材料,用于制造高果糖玉米糖浆;三乙酸纤维素,可用做使牛乳中所含乳糖分解的乳糖酶制剂的固定材料;二乙基氨基纤维素、戊二醛和高碘酸,可用做葡萄糖异构酶制剂(符合本章§184.1372 要求)的固定材料,用于制造果葡糖浆;聚乙烯亚胺与1,2-二氯乙烷的反应产物,可用做啤酒制造中所用得自黑曲霉的葡萄糖淀粉酶酶制剂的固定材料,也可用做葡萄糖异构酶制剂的固定材料,用于制造果葡糖浆。
发布单位
FDA
FDA
发布文号 67 FR 42716
发布日期 2002-06-25 生效日期 暂无
有效性状态 废止日期 暂无
备注 可安全用于酶制剂固定的固定剂物质包括:丙烯酰胺丙烯酸树脂,可用做葡萄糖异构酶制剂(符合本章§184.1372 要求)的固定材料,用于制造高果糖玉米糖浆;三乙酸纤维素,可用做使牛乳中所含乳糖分解的乳糖酶制剂的固定材料;二乙基氨基纤维素、戊二醛和高碘酸,可用做葡萄糖异构酶制剂(符合本章§184.1372 要求)的固定材料,用于制造果葡糖浆;聚乙烯亚胺与1,2-二氯乙烷的反应产物,可用做啤酒制造中所用得自黑曲霉的葡萄糖淀粉酶酶制剂的固定材料,也可用做葡萄糖异构酶制剂的固定材料,用于制造果葡糖浆。

  § 173.357   Materials used as fixing agents in the immobilization of enzyme preparations.

  Fixing agents may be safely used in the immobilization of enzyme preparations in accordance with the following conditions:

  (a) The materials consist of one or more of the following:

  (1) Substances generally recognized as safe in food.

  (2) Substances identified in this subparagraph and subject to such limitations as are provided:

Substances Limitations
Acrylamide-acrylic acid resin: Complying with §173.5(a)(1) and (b) of this chapter May be used as a fixing material in the immobilization of glucose isomerase enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance with §184.1372 of this chapter.
Cellulose triacetate May be used as a fixing material in the immobilization of lactase for use in reducing the lactose content of milk.
Diethylaminoethyl-cellulose May be used as a fixing material in the immobilization of glucose isomerase enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance with §184.1372 of this chapter.
Dimethylamine-epichlorohydrin resin: Complying with §173.60(a) and (b) of this chapter May be used as a fixing material in the immobilization of glucose isomerase enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance with §184.1372 of this chapter.
Glutaraldehyde  Do.
Periodic acid (CAS Reg. No. 10450–60–9).  
Polyethylenimine reaction product with 1,2-dichloroethane (CAS Reg. No. 68130–97–2) is the reaction product of homopolymerization of ethylenimine in aqueous hydrochloric acid at 100 °C and of cross-linking with 1,2-dichloroethane. The finished polymer has an average molecular weight of 50,000 to 70,000 as determined by gel permeation chromatography. The analytical method is entitled “Methodology for Molecular Weight Detection of Polyethylenimine,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Division of Petition Control, Center for Food Safety and Applied Nutrition (HFS–200), 5100 Paint Branch Pkwy., College Park, MD 20740, and may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

  May be used as a fixing material in the immobilization of glucoamylase enzyme preparations from Aspergillus niger for use in the manufacture of beer.

  May be used as a fixing material in the immobilization of:

  1. Glucose isomerase enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance with §184.1372 of this chapter.

  2. Glucoamylase enzyme preparations from Aspergillus niger for use in the manufacture of beer. Residual ethylenimine in the finished polyethylenimine polymer will be less than 1 part per million as determined by gas chromatography-mass spectrometry. The residual ethylenimine is determined by an analytical method entitled “Methodology for Ethylenimine Detection in Polyethylenimine,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Residual 1,2-dichloroethane in the finished polyethylenimine polymer will be less than 1 part per million as determined by gas chromatography. The residual 1,2-dichloroethane is determined by an analytical method entitled, “Methodology for Ethylenedichloride Detection in Polyethylenimine,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Division of Petition Control, Center for Food Safety and Applied Nutrition (HFS–215), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.


     (b) The fixed enzyme preparation is washed to remove residues of the fixing materials.

  [48 FR 5716, Feb. 8, 1983, as amended at 52 FR 39512, Oct. 22, 1987; 55 FR 12172, Apr. 2, 1990; 59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, 1996; 61 FR 14245, Apr. 1, 1996; 67 FR 42716, June 25, 2002]

  更多关于美国 FDA 可直接加入食品中的辅助性食品添加剂的种类法规,请点击美国FDA 21 CFR 第173部分可直接加入食品中的辅助性食品添加剂种类汇总

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