[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: 21CFR173.150]

[Page 122-123]
 
                        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 B--Enzyme Preparations and Microorganisms
 
Sec. 173.150  Milk-clotting enzymes, microbial.

    Milk-clotting enzyme produced by pure-culture fermentation process 
may be safely used in the production of cheese in accordance with the 
following prescribed conditions:
    (a) Milk-clotting enzyme is derived from one of the following 
organisms by a pure-culture fermentation process:
    (1) Endothia parasitica classified as follows: Class, Ascomycetes; 
order, Sphaeriales; family, Diaporthacesae; genus, Endothia; species, 
parasitica.
    (2) Bacillus cereus classified as follows: Class, Schizomycetes; 
order, Eubacteriales; family, Bacillaceae; genus, Bacillus; species, 
cereus (Frankland and Frankland).
    (3) Mucor pusillus Lindt classified as follows: Class, Phycomycetes; 
subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, 
Mucor; species, pusillus; variety, Lindt.
    (4) Mucor miehei Cooney et Emerson classified as follows: Class, 
Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, 
Mucoraceae; genus, Mucor; species, miehei; variety, Cooney et Emerson.
    (5) Aspergillus oryzae modified by recombinant deoxyribonucleic 
(DNA) techniques to contain the gene coding for aspartic proteinase from 
Rhizomucor miehei var. Cooney et Emerson as defined in paragraph (a)(4) 
of this section, and classified as follows: Class, Blastodeuteromycetes 
(Hyphomycetes); order, Phialidales (Moniliales); genus, Aspergillus; 
species oryzae.
    (b) The strains of organism identified in paragraph (a) of this 
section are nonpathogenic and nontoxic in man or other animals.
    (c) The additive is produced by a process that completely removes 
the generating organism from the milk-clotting enzyme product.
    (d) The additive is used in an amount not in excess of the minimum 
required to produce its intended effect in the production of those 
cheeses for which

[[Page 123]]

it is permitted by standards of identity established pursuant to section 
401 of the Act.

[42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 
62 FR 59284, Nov. 3, 1997]