§ 184.1538 - Nisin preparation.

§ 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. 1414-45-51414–45–5), 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 Staff (HFA-305HFA–305), Food and Drug Administration, 5630 Fishers Lane, rmRm. 1061, Rockville, MD 20852, 240–402–7500, between 9 a.m. and 4 p.m., Monday through Friday, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(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 § 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 § 133.175; pasteurized cheese spread with fruits, vegetables, or meats as defined in § 133.176; pasteurized process cheese spread as defined in § 133.179; pasteurized process cheese spread with fruits, vegetables, or meats as defined in § 133.180 of this chapter.

(d) The ingredient is used at levels not to exceed good manufacturing practice in accordance with § 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 Staff (HFA-305HFA–305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.5630 Fishers Lane, Rm. 1061, Rockville, MD 20857, 20852, 240–402–7500, between 9 a.m. and 4 p.m., Monday through Friday, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

[53 FR 11250, Apr. 6, 1988, as amended at 59 FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, 2003; 88 FR 17724, Mar. 24, 2023]