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: May be used as a fixing material
Complying with Sec. 173.5(a)(1) 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.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. in the immobilization of
No. 68130-97-2) is the reaction glucoamylase enzyme preparations
product of homopolymerization of from Aspergillus niger for use
ethylenimine in aqueous hydrochloric in the manufacture of beer.
acid at 100 C and of cross-linking May be used as a fixing material
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/ chromatography. The residual 1,2-
ibr_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]