21 C.F.R. § 173.357 Materials used as fixing agents in the immobilization of enzyme preparations.
Title 21 - Food and Drugs
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: (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]
Title 21: Food and Drugs
PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
Subpart D—Specific Usage Additives
§ 173.357 Materials used as fixing agents in the immobilization of enzyme preparations.
------------------------------------------------------------------------ Substances Limitations------------------------------------------------------------------------Acrylamide-acrylic acid resin: May be used as a fixing material Complying with § 173.5(a)(1) in the immobilization of glucose and (b) of this chapter. 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: May be used as a fixing material Complying with § 173.60(a) and in the immobilization of glucose (b) of this chapter. 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 May be used as a fixing material with 1,2-dichloroethane (CAS Reg.No. in the immobilization of 68130-97-2) is the reaction product glucoamylase enzyme preparations of homopolymerization of from Aspergillus niger for use ethylenimine in aqueous hydrochloric in the manufacture of beer. acid at 100 °C and of cross- May be used as a fixing material linking with 1,2-dichloroethane. The in the immobilization of: finished polymer has an average 1. Glucose isomerase enzyme molecular weight of 50,000 to 70,000 preparations for use in the as determined by gel permeation manufacture of high fructose chromatography. The analytical corn syrup, in accordance with method is entitled ``Methodology for § 184.1372 of this chapter. Molecular Weight Detection of 2. Glucoamylase enzyme Polyethylenimine,'' which is preparations from Aspergillus incorporated by reference in niger for use in the manufacture accordance with 5 U.S.C. 552(a) and of beer. Residual ethylenimine 1 CFR part 51. Copies may be in the finished polyethylenimine obtained from the Division of polymer will be less than 1 part Petition Control, Center for Food per million as determined by gas Safety and Applied Nutrition (HFS- chromatography-mass 200), 5100 Paint Branch Pkwy., spectrometry. The residual College Park, MD 20740, and may be ethylenimine is determined by an examined at the Center for Food analytical method entitled Safety and Applied Nutrition's ``Methodology for Ethylenimine Library, 5100 Paint Branch Pkwy., Detection in Polyethylenimine,'' College Park, MD 20740, or at the which is incorporated by National Archives and Records reference in accordance with 5 Administration (NARA). For U.S.C. 552(a) and 1 CFR part 51. information on the availability of Residual 1,2-dichloroethane in this material at NARA, call 202-741- the finished polyethylenimine 6030, or go to: http:// polymer will be less than 1 part www.archives.gov/federal_register/ per million as determined by gas code_of_federal_regulations/ chromatography. The residual 1,2- ibr_locations.php.. 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.php.------------------------------------------------------------------------
