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Food and Drug Administration, HHS § 146.132

Cosmetic Act; or if they are food addi- scribing the color: for example, ‘‘Fro- tives as so defined, they are used in zen concentrate for pink ’’. conformity with regulations estab- (c) Label declaration. Each of the in- lished pursuant to section 409 of the gredients used in the food shall be de- act. clared on the label as required by the (b) [Reserved] applicable sections of parts 101 and 130 (c) The name of the food is ‘‘Frozen of this chapter. concentrate for artificially sweetened [42 FR 14433, Mar. 15, 1977, as amended at 58 lemonade’’. The words ‘‘artificially FR 2881, Jan. 6, 1993] sweetened’’ shall be of the same size and style of type as the word ‘‘lem- § 146.132 . onade’’. (a) Identity—(1) Description. - (d) If an optional thickening or dis- fruit juice is the unfermented juice, in- persing ingredient referred to in para- tended for direct consumption, ob- graph (a) of this section is used, the tained by mechanical process from label shall bear the statement ‘‘lll sound, mature grapefruit ( added’’ or ‘‘with added lll’’, the paradisi Macfadyen) from which seeds blank being filled in with the common and peel (except embryonic seeds and name of the thickening or dispersing small fragments of seeds and peel agent used. Such statement shall be set which cannot be separated by good forth on the label with such promi- manufacturing practice) and excess nence and conspicuousness as to render pulp are removed and to which may be it likely to be read and understood by added not more than 10 percent by vol- the ordinary individual under cus- ume of the unfermented juice obtained tomary conditions of purchase. from mature hybrids of grapefruit. The (e) Frozen concentrate for artificially juice may be adjusted by the addition sweetened lemonade is labeled to con- of the optional concentrated grapefruit form to the labeling requirements pre- juice ingredients specified in paragraph scribed for foods which purport to be or (a)(2) of this section, but the quantity are represented for special dietary use of such concentrated by regulations promulgated pursuant ingredient added shall not contribute to section 403(j) of the act. more than 15 percent of the grapefruit (f) Label declaration. Each of the in- juice soluble solids in the finished food. gredients used in the food shall be de- The grapefruit pulp, grapefruit oil, and clared on the label as required by the grapefuit essence (components derived applicable sections of parts 101 and 130 from grapefruit) content may be ad- of this chapter. justed in accordance with good manu- facturing practice. The juice may have [42 FR 14433, Mar. 15, 1977, as amended at 58 been concentrated and later reconsti- FR 2881, Jan. 6, 1993] tuted with water suitable for the pur- pose of maintaining essential composi- § 146.126 Frozen concentrate for col- tion and quality factors of the juice. It ored lemonade. may be sweetened with the dry nutri- (a) Frozen concentrate for colored tive sweeteners referred to in para- lemonade conforms to the definition graph (a)(2)(iii) of this section. If the and standard of identity prescribed for grapefruit juice is prepared from con- frozen concentrate for lemonade by centrate, such sweeteners, in liquid § 146.120, except that it is colored with a form, referred to in paragraph (a)(2)(iii) safe and suitable fruit juice, vegetable of this section, also may be used. When juice, or any such juice in concentrated prepared from concentrated grapefruit form, or with any other color additive juice, exclusive of added sweeteners, ingredient suitable for use in food, in- the finished food contains not less than cluding artificial coloring, used in con- 10 percent, by weight, of soluble solids formity with regulations established taken as the refractometric pursuant to section 721 of the Federal value (of the filtrate), corrected to 20 Food, Drug, and Cosmetic Act. °C, and corrected for acidity by adding (b) The name of the food is ‘‘Frozen (0.012+0.193x–0.0004x2), where x equals concentrate for lll lemonade’’, the the percent anhydrous in blank being filled in with the word de- the sample, to the refractometrically

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VerDate Mar<15>2010 16:52 May 15, 2014 Jkt 232071 PO 00000 Frm 00529 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT ofr150 PsN: PC150 § 146.135 21 CFR Ch. I (4–1–14 Edition)

obtained sucrose value by the first water and/or grapefruit juice; or (2) if method prescribed in ‘‘Correction of the food is prepared from grapefuit Refractometer Sucrose Readings for juice from concentrate and grapefruit Citric Acid Content for Lemonade,’’ by juice. The words ‘‘from concentrate’’ Yeatman, Senzel, and Springer, ‘‘Jour- shall be shown in letters not less than nal of the Association of Official Ana- one-half the height of the letters in the lytical Chemists,’’ vol. 59 p. 368 (1976). words ‘‘grapefruit juice.’’ Copies are available from the AOAC (ii) If any nutritive sweetener is INTERNATIONAL, 481 North Frederick added, the principal display panel of Ave., suite 500, Gaithersburg, MD 20877, the label shall bear the statement or available for inspection at the Na- ‘‘Sweetener added.’’ If no sweetener is tional Archives and Records Adminis- added, the word ‘‘unsweetened’’ may tration (NARA). For information on immediately precede or follow the the availability of this material at words ‘‘Grapefruit Juice’’ or ‘‘Grape- NARA, call 202–741–6030, or go to: http:// fruit Juice from Concentrate.’’ www.archives.gov/federallregister/ (iii) Label declaration. Each of the in- codeloflfederallregulations/ gredients used in the food shall be de- ibrllocations.html. The food may con- clared on the label as required by the tain one or any combination of the op- applicable sections of parts 101 and 130 tional ingredients specified in para- of this chapter. graph (a)(2) of this section. Grapefruit (b) [Reserved] juice, as defined in this paragraph, may (c) Fill of container. (1) The standard be preserved by heat sterlization (can- of fill of container for grapefruit juice, ning), refrigeration, or freezing. When except when the food is frozen, is not sealed in a container to be held at am- less than 90 percent of the total capac- bient temperatures, it is so processed ity of the container as determined by by heat, before or after sealing, as to the general method for fill of container prevent spoilage. prescribed in § 130.12(b) of this chapter. (2) Optional ingredients. The optional (2) Compliance is determined as spec- ingredients referred to in paragraph ified in § 146.3(g)(2). (a)(1) of this section are: (i) Concentrated grapefruit juice (3) If the grapefruit juice fails to (grapefruit juice from which part of the meet the standard of fill as prescribed water has been removed). in paragraphs (c) (1) and (2) of this sec- (ii) Water and/or grapefruit juice to tion, the label shall bear the general reconstitute concentrated grapefruit statement of substandard fill specified juice in the manufacture of grapefruit in § 130.14(b) of this chapter, in the juice from concentrate. manner and form therein prescribed. (iii) One or any combination of two [46 FR 8464, Jan. 27, 1981; 46 FR 21359, Apr. 10, or more of the dry or liquid forms of 1981; 46 FR 26300, May 12, 1981, as amended at , invert sugar sirup, dextrose, glu- 47 FR 11830, Mar. 19, 1982; 47 FR 24287, June cose sirup, and fructose. Sweeteners de- 4, 1982; 47 FR 43364, Oct. 1, 1982; 58 FR 2881, fined in part 168 of this chapter shall be Jan. 6, 1993; 66 FR 17359, Mar. 30, 2001] as defined therein. (3) Labeling. (i) The name of the food § 146.135 juice. is: (a) is the unfermented (a) ‘‘Grapefruit juice’’ (1) if the food juice obtained from mature oranges of is prepared from unconcentrated, undi- the species Citrus sinensis or of the cit- luted liquid extracted from mature rus hybrid commonly called grapefruit; or (2) if the food is prepared ‘‘Ambersweet’’ (1⁄2 Citrus sinensis X 3⁄8 from unconcentrated, undiluted liquid Citrus reticulata X 1⁄8 Citrus paradisi extracted from mature grapefruit to (USDA Selection:1–100–29: 1972 which concentrated grapefruit juice is Whitmore Foundation Farm)). Seeds added to adjust soluble solids as pro- (except embryonic seeds and small vided for in paragraph (a)(1) of this sec- fragments of seeds that cannot be sepa- tion. rated by current good manufacturing (b) ‘‘Grapefruit juice from con- practice) and excess pulp are removed. centrate’’ (1) if the food is prepared The juice may be chilled, but it is not from concentrated grapefruit juice and frozen.

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