§184.1538 食品添加剂乳酸链球菌肽制�?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�C45�C5�? 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�C305�? 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�C741�C6030, or go to:http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

　　�?� Nisin content, not less than 900 international units per milligram.

　　�?� Arsenic, not more than 1 part per million.

　　�?� Lead, not more than 2 parts per million.

　　�?� Zinc, not more than 25 parts per million.

　　�?� Copper, zinc plus copper not more than 50 parts per million.

　　�?� Total plate count, not more than 10 per gram.

　　�?� Escherichia coli, absent in 10 grams.

　　�?� Salmonella, absent in 10 grams.

　　�?� 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 exceedgood manufacturing practicein 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 �?974�? which is incorporated by reference. Copies are available from the Division of Dockets Management （HFA�C305�? Food and Drug Administration, rm. 1�C23, 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�C741�C6030, 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]