21 C.F.R. § 173.130

Current through October 31, 2024
Section 173.130 - Carbohydrase derived from Rhizopus oryzae.

Carbohydrase from Rhizopus oryzae may be safely used in the production of dextrose from starch in accordance with the following prescribed conditions:

(a)Rhizopus oryzae is classified as follows: Class, Phycomycetes; order, Mucorales; family, Mucoraceae; genus, Rhizopus; species, Rhizopus oryzae.
(b) The strain of Rhizopus oryzae is nonpathogenic and nontoxic.
(c) The carbohydrase is produced under controlled conditions to maintain nonpathogenicity and nontoxicity, including the absence of aflatoxin.
(d) The carbohydrase is produced by a process which completely removes the organism Rhizopus oryzae from the carbohydrase product.
(e) The carbohydrase is maintained under refrigeration from production to use and is labeled to include the necessity of refrigerated storage.

21 C.F.R. §173.130