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184.1685 Rennet (animal-derived) and chymosin preparation (fermentation-derived).

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1685 Rennet (animal-derived) and chymosin preparation (fermentation-derived).



[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: 21CFR184.1685]

[Page 558-559]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS 
SAFE--Table of Contents
 
        Subpart B_Listing of Specific Substances Affirmed as GRAS
 
Sec.  184.1685  Rennet (animal-derived) and chymosin preparation 
(fermentation-derived).

    (a)(1) Rennet and bovine rennet are commercial extracts containing 
the active enzyme rennin (CAS Reg. No. 9001-98-3), also known as 
chymosin (International Union of Biochemistry Enzyme Commission (E.C.) 
3.4.23.4). Rennet is the aqueous extract prepared from cleaned, frozen, 
salted, or dried fourth stomachs (abomasa) of calves, kids, or lambs. 
Bovine rennet is the product from adults of the animals listed above. 
Both products are called rennet and are clear amber to dark brown liquid 
preparations or white to tan powders.
    (2) Chymosin preparation is a clear solution containing the active 
enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a 
nonpathogenic and nontoxigenic strain of Escherichia coli K-12 
containing the prochymosin gene. The prochymosin is isolated as an 
insoluble aggregate that is acid-treated to destroy residual cellular 
material and, after solubilization, is acid-treated to form chymosin. It 
must be processed with materials that are generally recognized as safe, 
or are food additives that have been approved by the Food and Drug 
Administration for this use.
    (3) Chymosin preparation is a clear solution containing the active 
enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a 
nonpathogenic and nontoxigenic strain of Kluyveromyces marxianus variety 
lactis, containing the prochymosin gene. The prochymosin is secreted by 
cells into fermentation broth and converted to chymosin by acid 
treatment. All materials used in the processing and formulating of 
chymosin must be either generally recognized as safe (GRAS), or be food 
additives that have been approved by the Food and Drug Administration 
for this use.
    (4) Chymosin preparation is a clear solution containing the active 
enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a 
nonpathogenic and nontoxigenic strain of Aspergillus niger van Tieghem 
variety awamori (Nakazawa) Al-Musallam (synonym A. awamori Nakazawa) 
containing the prochymosin gene. Chymosin is recovered from the 
fermentation broth after acid treatment. All materials used in the 
processing and formulating of chymosin preparation must be either 
generally recognized as safe (GRAS) or be food additives that have been 
approved by the Food and Drug Administration for this use.
    (b) Rennet and chymosin preparation meet the general and additional 
requirements for enzyme preparations of the ``Food Chemicals Codex,'' 3d 
Ed. (1981), pp. 107-110, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a). Copies are available from the National 
Academy Press, 2101 Constitution Avenue NW., Washington, DC 20418, or 
are available for inspection 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.
    (c) In accordance with Sec.  184.1(b)(1), the ingredient is used in 
food with no limitation other than current good

[[Page 559]]

manufacturing practice. The affirmation of this ingredient as generally 
recognized as safe as a direct human food ingredient is based upon the 
following current good manufacturing practice conditions of use:
    (1) The ingredient is used as an enzyme as defined in Sec.  
170.3(o)(9) of this chapter; a processing aid as defined in Sec.  
170.3(o)(24) of this chapter; and a stabilizer and thickener as defined 
in Sec.  170.3(o)(28) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: In cheeses as defined in 
Sec.  170.3(n)(5) of this chapter; frozen dairy desserts and mixes as 
defined in Sec.  170.3(n)(20) of this chapter; gelatins, puddings, and 
fillings as defined in Sec.  170.3(n)(22) of this chapter; and milk 
products as defined in Sec.  170.3(n)(31) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[55 FR 10935, Mar. 23, 1990, as amended at 57 FR 6479, Feb. 25, 1992; 58 
FR 27202, May 7, 1993]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1685


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