(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

Dockets Management Branch (HFA-305), Food and Drug Administration, rm.

1-23, 12420 Parklawn Dr., Rockville, MD 20857, or available for

inspection at the Office of the Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC 20408.

(1) Nisin content, not less than 900 international units per

milligram.

(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 Dockets Management Branch (HFA-

305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857, or available for inspection at the Office of the

Federal Register, 800 North Capitol Street, NW., suite 700, Washington,

DC 20408.

[53 FR 11250, Apr. 6, 1988, as amended at 59 FR 14364, Mar. 28, 1994]