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Food and Drug Administration, HHS § 172.167

§ 172.155 Natamycin (pimaricin). § 172.165 Quaternary ammonium chlo- ride combination. (a) Natamycin (CAS Reg. No. 7681–93– 8), also known as pimaricin, is a pol- The food additive, quaternary ammo- yene macrolide antimycotic substance nium combination, may be possessing an empirical formula of safely used in food in accordance with the following conditions: C33H47NO13 and a molecular weight of 665.7. (a) The additive contains the fol- (b) The additive shall conform to the lowing compounds: n-dodecyl dimethyl following specifications: benzyl ammonium chloride (CAS Reg. No. 139–07–1); n-dodecyl dimethyl ethyl- Purity: 97 percent ±2 percent on an anhy- benzyl ammonium chloride (CAS Reg. drous basis. No. 27479–28–3); n-hexadecyl dimethyl Arsenic: Not more than 1 part per million. benzyl ammonium chloride (CAS Reg. Heavy metals (as Pb): Not more than 20 parts No. 122–18–9); n-octadecyl dimethyl per million. benzyl ammonium chloride (CAS Reg. (c) The additive may be applied on No. 122–19–0); n-tetradecyl dimethyl cheese, as an antimycotic, in amounts benzyl ammonium chloride (CAS Reg. not to exceed 20 milligrams per kilo- No. 139–08–2); n-tetradecyl dimethyl gram (20 parts per million) in the fin- ethylbenzyl ammonium chloride (CAS ished product as determined by Inter- Reg. No. 27479–29–4). national Dairy Federation (IDF) Stand- (b) The additive meets the following ard 140A:1992, ‘‘Cheese and Cheese specifications: pH (5 percent active so- Rind-Determination of Natamycin Con- lution) 7.0–8.0; total amines, maximum tent-Method by Molecular Absorption 1 percent as combined free amines and Spectrometry and by High-Perform- amine hydrochlorides. ance Liquid Chromatography,’’ which (c) The additive is used as an anti- is incorporated by reference. The Di- microbial agent, as defined in rector of the Office of the Federal Reg- § 170.3(o)(2) of this chapter, in raw sugar ister approves this incorporation by cane juice. It is added prior to clari- reference in accordance with 5 U.S.C. fication when further processing of the 552(a) and 1 CFR part 51. Copies are sugar cane juice must be delayed. available from the Division of Product (d) The additive is applied to the Policy (HFS–206), Center for Food Safe- sugar juice in the following quantities, ty and Applied Nutrition, Food and based on the weight of the raw cane: Drug Administration, 5100 Paint Parts per Branch Pkwy., College Park, MD 20740, Component million or may be examined at the Center for n-Dodecyl dimethyl benzyl ammonium chloride 0.25–1.0 Food Safety and Applied Nutrition’s n-Dodecyl dimethyl ethylbenzyl ammonium Library, 5100 Paint Branch Pkwy., Col- chloride ...... 3.4–13.5 lege Park, MD 20740, or at the National n-Hexadecyl dimethyl benzyl ammonium chlo- Archives and Records Administration ride ...... 1.5–6.0 n-Octadecyl dimethyl benzyl ammonium chlo- (NARA). For information on the avail- ride ...... 0.25–1.0 ability of this material at NARA, call n-Tetradecyl dimethyl benzyl ammonium chlo- 202–741–6030, or go to: http:// ride ...... 3.0–12.0 n-Tetradecyl dimethyl ethylbenzyl ammonium www.archives.gov/federallregister/ chloride ...... 1.6–6.5 codeloflfederallregulations/ ibrllocations.html. [50 FR 3890, Jan. 29, 1985] [47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, § 172.167 and hydrogen 1998; 66 FR 13847, Mar. 8, 2001] peroxide solution. An aqueous solution containing a § 172.160 Potassium nitrate. mixture of silver nitrate and hydrogen The food additive potassium nitrate peroxide may be safely used in accord- may be safely used as a curing agent in ance with the following prescribed con- the processing of cod roe, in an amount ditions: not to exceed 200 parts per million of (a) The additive is used as an anti- the finished roe. microbial agent in bottled water.

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(b) meets the at the National Archives and Records specifications of the ‘‘Food Chemicals Administration (NARA). For informa- Codex,’’ 6th ed. (2008), pp. 463 and 464, tion on the availability of this mate- which is incorporated by reference. The rial at NARA, call 202–741–6030 or go to: Director of the Federal Register ap- http://www.archives.gov/federallregister/ proves this incorporation by reference codelofl federallregulations/ in accordance with 5 U.S.C. 552(a) and 1 ibrllocations.html. CFR part 51. You may obtain copies (e) Substances generally recognized from the United States Pharmacopeial as safe in or on food may be used to Convention, 12601 Twinbrook Pkwy., stabilize the additive to ensure that Rockville, MD 20852 (Internet address the additive will perform its intended http://www.usp.org). Copies may be ex- technical effect. amined at the Center for Food Safety (f) The additive may not be added to and Applied Nutrition’s Library, Food bottled water that has been filtered or and Drug Administration, 5100 Paint is intended to be filtered through a sil- Branch Pkwy., College Park, MD 20740, ver-containing water filter. 301–436–2163, or at the National Ar- (g) Bottled water must meet the chives and Records Administration quality standards for bottled water in (NARA). For information on the avail- § 165.110(b)(2) through (b)(5) of this ability of this material at NARA, call chapter, including the limits specified 202–741–6030 or go to: http:// for total silver and nitrate, unless the www.archives.gov/federallregister/ water bears a label statement of sub- codeloflfederallregulations/ standard quality, as provided for under ibrllocations.html. § 165.110(c) of this chapter. (c) The amount of silver added will not exceed 17 micrograms per kilogram [74 FR 11478, Mar. 18, 2009] in the treated bottled water, and the amount of hydrogen peroxide will not § 172.170 Sodium nitrate. exceed 23 milligrams per kilogram in The food additive sodium nitrate the treated bottled water. Analyses for may be safely used in or on specified silver and hydrogen peroxide shall be foods in accordance with the following conducted on samples of treated bot- prescribed conditions: tled water at the site of bottling, using (a) It is used or intended for use as samples of the water intended for follows: treatment for the blank determination. (d)(1) The amount of silver in the (1) As a preservative and color fixa- treated bottled water is determined tive, with or without sodium nitrite, in using the method for silver designated smoked, cured sablefish, smoked, cured in 21 CFR 165.110(b)(4)(iii)(G)(2)(i). salmon, and smoked, cured shad, so (2) The amount of hydrogen peroxide that the level of sodium nitrate does in the treated bottled water is deter- not exceed 500 parts per million and the mined using a Hydrogen Peroxide Test level of sodium nitrite does not exceed Kit from the HACH Co., or equivalent. 200 parts per million in the finished The manual from the Hydrogen Per- product. Test Kit, Model HYP–1, Catalog (2) As a preservative and color fixa- Number 22917–00, 1991, is incorporated tive, with or without sodium nitrite, in by reference. The Director of the Fed- meat-curing preparations for the home eral Register approves this incorpora- curing of meat and meat products (in- tion by reference in accordance with 5 cluding poultry and wild game), with U.S.C. 552(a) and 1 CFR part 51. You directions for use which limit the may obtain copies of the test kit man- amount of sodium nitrate to not more ual from the HACH Co., P.O. Box 389, than 500 parts per million in the fin- Loveland CO, 80359 (1–800–227–4224), ished meat product and the amount of Model HYP–1, Catalog Number 22917–00. sodium nitrite to not more than 200 Copies may be examined at the Center parts per million in the finished meat for Food Safety and Applied Nutri- product. tion’s Library, Food and Drug Admin- (b) To assure safe use of the additive, istration, 5100 Paint Branch Pkwy., in addition to the other information re- College Park, MD 20740, 301–436–2163, or quired by the Act:

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