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

Home > Regulations > Secondary direct food additives permitted in food for human consumption > 173.357 Materials used as fixing agents in the immobilization of enzyme preparations.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.357]

[Page 147-148]
 
                        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:

[[Page 148]]

    (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:         May be used as a fixing material
 Complying with Sec.   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 Sec.   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 Sec.   184.1372
                                        of this chapter.
Dimethylamine-epichlorohydrin resin:   May be used as a fixing material
 Complying with Sec.   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 Sec.   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 [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), 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/ibr--   chromatography. The residual 1,2-
 locations.html..                       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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 173, Section 357


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