Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 3 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)
/ 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.
§ 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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, and may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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: | May be used as a fixing material in the immobilization of glucoamylase enzyme preparations from 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 |
(b) The fixed enzyme preparation is washed to remove residues of the fixing materials.