[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
SAFE--Table of Contents
Subpart B_Listing of Specific Substances Affirmed as GRAS
Sec. 184.1538 Nisin preparation.
(a) Nisin preparation is derived from pure culture fermentations of
certain strains of Streptococcus lactis Lancefield Group N. Nisin
preparation contains nisin (CAS Reg. No. 1414-45-5), a group of related
peptides with antibiotic activity.
(b) The ingredient is a concentrate or dry material that meets the
specifications that follow when it is tested as described in
``Specifications for Identity and Purity of Some Antibiotics,'' World
Health Organization, FAO Nutrition Meeting Report Series, No. 45A, 1969,
which is incorporated by reference. Copies are available from the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or 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/
(1) Nisin content, not less than 900 international units per
(2) Arsenic, not more than 1 part per million.
(3) Lead, not more than 2 parts per million.
(4) Zinc, not more than 25 parts per million.
(5) Copper, zinc plus copper not more than 50 parts per million.
(6) Total plate count, not more than 10 per gram.
(7) Escherichia coli, absent in 10 grams.
(8) Salmonella, absent in 10 grams.
(9) Coagulase positive staphylococci, absent in 10 grams.
(c) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter to inhibit the outgrowth of
Clostridium botulinum spores and toxin formation in pasteurized cheese
spreads and pasteurized process cheese spreads listed in Sec. 133.175;
pasteurized cheese spread with fruits, vegetables, or meats as defined
in Sec. 133.176; pasteurized process cheese spread as defined in Sec.
133.179; pasteurized process cheese spread with fruits, vegetables, or
meats as defined in Sec. 133.180 of this chapter.
(d) The ingredient is used at levels not to exceed good
manufacturing practice in accordance with Sec. 184.1(b)(1) of this
chapter. The current good manufacturing practice level is the quantity
of the ingredient that delivers a maximum of 250 parts per million of
nisin in the finished product as determined by the British Standards
Institution Methods, ``Methods for the Estimation and Differentiation of
Nisin in Processed Cheese,'' BS 4020 (1974), which is incorporated by
reference. Copies are available from the Division of Dockets Management
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857, or 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:
[53 FR 11250, Apr. 6, 1988, as amended at 59 FR 14364, Mar. 28, 1994; 68
FR 24879, May 9, 2003]
Additives that reference this regulation: