21 CFR Ch. I (4–1–14 Edition) § 164.150

§ 164.150 21 CFR Ch. I (4–1–14 Edition)

minus three-eighths inch (0.953 centi- suite 500, Gaithersburg, MD 20877, or meter) and the diameter to be the out- may be examined at the National Ar- side diameter at the double seam chives and Records Administration minus one-eighth inch (0.318 centi- (NARA). For information on the avail- meter). For fiber-bodied containers ability of this material at NARA, call with indented ends (that is, fiber-bod- 202–741–6030, or go to: http:// ied cans with metal ends attached by www.archives.gov/federallregister/ double seams), consider the height to codeloflfederallregulations/ be the outside height at the double ibrllocations.html. seam minus three-eighths inch (0.953 (b) The peanut ingredients referred to centimeter) and the diameter to be the in paragraph (a) of this section are: outside diameter at the double seam minus three-sixteenths inch (0.476 cen- (1) Blanched peanuts, in which the timeter). germ may or may not be included. (iii) Calculate the percent fill of the (2) Unblanched peanuts, including the container as follows: Divide the aver- skins and germ. age volume of nuts found according to (c) The seasoning and stabilizing in- paragraph (c)(2)(i) of this section by gredients referred to in paragraph (a) the appropriate container volume of this section are suitable substances found according to paragraph (c)(2)(ii) which are not food additives as defined of this section and multiply by 100. The in section 201(s) of the Federal Food, result shall be considered to be the per- Drug, and Cosmetic Act (the act), or if cent fill of the container. they are food additives as so defined, (3) If shelled nuts fall below the they are used in conformity with regu- standard of fill of container prescribed lations established pursuant to section in paragraph (c)(1) of this section, the 409 of the act. Seasoning and stabi- label shall bear the general statement lizing ingredients that perform a useful of substandard fill specified in function are regarded as suitable, ex- § 130.14(b) of this chapter, in the man- cept that artificial flavorings, artifi- ner and form therein specified. cial sweeteners, chemical preserva- § 164.150 Peanut butter. tives, and color additives are not suit- able ingredients in peanut butter. Oil (a) Peanut butter is the food prepared products used as optional stabilizing by grinding one of the shelled and roasted peanut ingredients provided for ingredients shall be hydrogenated veg- by paragraph (b) of this section, to etable oils. For the purposes of this which may be added safe and suitable section, hydrogenated vegetable oil seasoning and stabilizing ingredients shall be considered to include partially provided for by paragraph (c) of this hydrogenated vegetable oil. section, but such seasoning and stabi- (d) If peanut butter is prepared from lizing ingredients do not in the aggre- unblanched peanuts as specified in gate exceed 10 percent of the weight of paragraph (b)(2) of this section, the the finished food. To the ground pea- name shall show that fact by some nuts, cut or chopped, shelled, and such statement as ‘‘prepared from roasted peanuts may be added. During unblanched peanuts (skins left on).’’ processing, the oil content of the pea- Such statement shall appear promi- nut ingredient may be adjusted by the nently and conspicuously and shall be addition or subtraction of peanut oil. in type of the same style and not less The fat content of the finished food than half of the point size of that used shall not exceed 55 percent when deter- for the words ‘‘peanut butter.’’ This mined as prescribed in ‘‘Official Meth- statement shall immediately precede ods of Analysis of the Association of or follow the words ‘‘peanut butter,’’ Official Analytical Chemists,’’ 13th Ed. without intervening written, printed, (1980), section 27.006(a) under ‘‘Crude or graphic matter. Fat—Official First Action, Direct Method,’’ in paragraph (a), which is in- (e) Label declaration. Each of the in- corporated by reference. Copies may be gredients used in the food shall be de- obtained from the AOAC INTER- clared on the label as required by the NATIONAL, 481 North Frederick Ave.,

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VerDate Mar<15>2010 16:52 May 15, 2014 Jkt 232071 PO 00000 Frm 00610 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT ofr150 PsN: PC150 Food and Drug Administration, HHS § 165.110

applicable sections of parts 101 and 130 Subpart B—Requirements for of this chapter. Specific Standardized Beverages [42 FR 14475, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982; 49 FR 10103, Mar. 19, § 165.110 Bottled water. 1984; 54 FR 24896, June 12, 1989; 58 FR 2886, (a) Identity—(1) Description. Bottled Jan. 6, 1993; 61 FR 9325, Mar. 8, 1996; 63 FR water is water that is intended for 14035, Mar. 24, 1998] human consumption and that is sealed in bottles or other containers with no PART 165—BEVERAGES added ingredients except that it may optionally contain safe and suitable Subpart A—General Provisions antimicrobial agents. Fluoride may be optionally added within the limitations Sec. established in § 165.110(b)(4)(ii). Bottled 165.3 Definitions. water may be used as an ingredient in beverages (e.g., diluted juices, flavored Subpart B—Requirements for Specific bottled waters). It does not include Standardized Beverages those food ingredients that are de- 165.110 Bottled water. clared in ingredient labeling as ‘‘water,’’ ‘‘carbonated water,’’ ‘‘dis- AUTHORITY: 21 U.S.C. 321, 341, 343, 343–1, 348, infected water,’’ ‘‘filtered water,’’ 349, 371, 379e. ‘‘seltzer water,’’ ‘‘soda water,’’ ‘‘spar- SOURCE: 60 FR 57124, Nov. 13, 1995, unless kling water,’’ and ‘‘tonic water.’’ The otherwise noted. processing and bottling of bottled water shall comply with applicable reg- Subpart A—General Provisions ulations in part 129 of this chapter. (2) Nomenclature. The name of the § 165.3 Definitions. food is ‘‘bottled water,’’ ‘‘drinking (a) A lot is: water,’’ or alternatively one or more of the following terms as appropriate: (1) For purposes of determining qual- (i) The name of water from a well ity factors related to manufacture, tapping a confined aquifer in which the processing, or packing, a collection of water level stands at some height primary containers or units of the above the top of the aquifer is ‘‘arte- same size, type, and style produced sian water’’ or ‘‘artesian well water.’’ under conditions as nearly uniform as Artesian water may be collected with possible and usually designated by a the assistance of external force to en- common container code or marking, or hance the natural underground pres- in the absence of any common con- sure. On request, plants shall dem- tainer code or marking, a day’s produc- onstrate to appropriate regulatory offi- tion. cials that the water level stands at (2) For purposes of determining qual- some height above the top of the aqui- ity factors related to distribution and fer. storage, a collection of primary con- (ii) The name of water from a sub- tainers or units transported, stored, or surface saturated zone that is under a held under conditions as nearly uni- pressure equal to or greater than at- form as possible. mospheric pressure is ‘‘ground water.’’ (b) A sample consists of 10 subsamples Ground water must not be under the di- (consumer units), one taken from each rect influence of surface water as de- of 10 different randomly chosen ship- fined in 40 CFR 141.2. ping cases to be representative of a (iii) The name of water containing given lot, unless otherwise specified in not less than 250 parts per million a specific standard in this part. (ppm) total dissolved solids (TDS), (c) An analytical unit is the portion(s) coming from a source tapped at one or of food taken from a subsample of a more bore holes or springs, originating from a geologically and physically pro- sample for the purpose of analysis. tected underground water source, may be ‘‘mineral water.’’ Mineral water shall be distinguished from other types

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