[Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR173.357] [Page 137-138] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION--Table of Contents Subpart D--Specific Usage Additives Sec. 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 ------------------------------------------------------------------------ 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 Sec. 184.1372 of this chapter. Glutaraldehyde....................... Do. Periodic acid (CAS Reg. No. 10450-60- 9).. [[Page 138]] 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 deg.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 Sec. 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), 200 C St. SW., Washington, DC spectrometry. The residual 20204, and may be examined at the ethylenimine is determined by an Center for Food Safety and Applied analytical method entitled Nutrition's Library, 200 C St. SW., ``Methodology for Ethylenimine rm. 3321, Washington, DC, or at the Detection in Polyethylenimine,'' Office of the Federal Register, 800 which is incorporated by North Capitol St. NW., suite 700, reference in accordance with 5 Washington, DC. 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), 200 C St. SW., Washington, DC 20204, or may be examined at the Center for Food Safety and Applied Nutrition's Library, 200 C St. SW., rm. 3321, Washington, DC, or the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. ------------------------------------------------------------------------ (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]