CFR Subpart B

CFR Subpart B
in effect

21 C.F.R. § 146.114 Lemon juice.

(a) Identity—(1) Description. Lemon juice is the unfermented juice, obtained by mechanical process, from sound, mature lemons (Citrus limon (L.) Burm. f.), from which seeds (except embryonic seeds and small fragments of seed which cannot be separated by good manufacturing practice) and excess pulp are removed. The juice may be adjusted by the addition of the optional concentrated lemon juice ingredient specified in paragraph (a)(2) of this section in such quantity so that the increase in acidity, calculated as anhydrous citric acid, does not exceed 15 percent of the acidity of the finished food. The lemon oil and lemon essence (derived from lemons) content may be adjusted in accordance with good manufacturing practice. The juice may have been concentrated and later reconstituted. When prepared from concentrated lemon juice, the finished food contains not less than 6 percent, by weight, of soluble solids taken as the refractometric sucrose value (of the filtrate), corrected to 20 °C, but uncorrected for acidity, in accordance with the “International Scale of Refractive Indices of Sucrose Solutions” in section 52.012 of “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), which is incorporated by reference, and has a titratable acidity content of not less than 4.5 percent, by weight, calculated as anhydrous citrus acid. Copies of the incorporation by reference may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The food may contain one or any combination of the safe and suitable optional ingredients specified in paragraph (a)(2) of this section. Lemon juice, as defined in this paragraph, may be preserved by heat sterilization (canning), refrigeration, freezing, or by the addition of safe and suitable preservatives. When sealed in a container to be held at ambient temperatures, it is preserved by the addition of safe and suitable preservatives or so processed by heat, before or after sealing, as to prevent spoilage. (2) Optional ingredients. The optional safe and suitable ingredients referred to in paragraph (a)(1) of this section are: (i) Concentrated lemon juice (lemon juice from which part of the water has been removed). (ii) Water and/or lemon juice to reconstitute concentrated lemon juice in the manufacture of lemon juice from concentrate. (iii) Preservatives. (3) Labeling. (i) The name of the food is: (a) “Lemon juice” (1) if the food is prepared from unconcentrated, undiluted liquid extracted from mature lemons; or (2) if the food is prepared from unconcentrated, undiluted liquid extracted from mature lemons to which concentrated lemon juice is added to adjust acidity as provided for in paragraph (a)(1) of this section. (b) “Lemon juice from concentrate” or “reconstituted lemon juice” (1) if the food is prepared from concentrated lemon juice and water and/or lemon juice; or (2) if the food is prepared from lemon juice from concentrate and lemon juice. The words “from concentrate” or “reconstituted” shall be shown in letters not less than one-half the height of the letters in the word “lemon juice.” (ii) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter. (b) [Reserved] (c) Fill of container. (1) The standard of fill of container for lemon juice, except when the food is frozen, is not less than 90 percent of the total capacity of the container as determined by the general method for fill of container prescribed in § 130.12(b) of this chapter, except (i) When the food is frozen or (ii) When the food is packaged in individual serving-size packages, containing 1/2 fluid ounce or less, for use as described in § 1.24(a)(3) of this chapter. (2) Compliance is determined as specified in § 146.3(g)(2). (3) If the lemon juice fails to meet the standard of fill as prescribed in paragraph (c) (1) and (2) of this section, the label shall bear the general statement of substandard fill specified in § 130.14(b) of this chapter, in the manner and form therein prescribed.

21 C.F.R. § 146.120 Frozen concentrate for lemonade.

(a) Frozen concentrate for lemonade is the frozen food prepared from one or both of the lemon juice ingredients specified in paragraph (b) of this section together with one or any mixture of safe and suitable nutritive carbohydrate sweeteners. The product contains not less than 48.0 percent by weight of soluble solids taken as the sucrose value determined by refractometer and corrected for acidity prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), section 22.025, “Frozen Concentrate for Lemonade (12),” under the heading “Soluble Solids by Refractometer—Official First Action,” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html When the product is diluted according to directions for making lemonade which shall appear on the label, the acidity of the lemonade, calculated as anhydrous citric acid, shall be not less than 0.70 gram per 100 milliliters, and the soluble solids, measured as described for the concentrate, shall be not less than 10.5 percent by weight. (b) The lemon juice ingredients referred to in paragraph (a) of this section are: (1) Lemon juice or frozen lemon juice or a mixture of these. (2) Concentrated lemon juice or frozen concentrated lemon juice or a mixture of these. (c) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

21 C.F.R. § 146.121 Frozen concentrate for artificially sweetened lemonade.

(a) Frozen concentrate for artificially sweetened lemonade conforms to the definition and standard of identity prescribed for frozen concentrate for lemonade by § 146.120, except that in lieu of nutritive sweeteners it is sweetened with one or more of the artificial sweetening ingredients listed in and complying with the requirements of parts 172, 180 or 184 of this chapter, and the soluble solids specifications prescribed in § 146.120(a) do not apply. When the product is diluted according to directions which shall appear on the label, the acidity of the artificially sweetened lemonade, calculated as anhydrous citric acid, shall be not less than 0.70 gram per 100 milliliters. It may contain one or more safe and suitable dispersing ingredients serving the function of distributing the lemon oil throughout the food. It may also contain one or more safe and suitable thickening ingredients. Such dispersing and thickening ingredients are not food additives as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act; or if they are food additives as so defined, they are used in conformity with regulations established pursuant to section 409 of the act. (b) [Reserved] (c) The name of the food is “Frozen concentrate for artificially sweetened lemonade”. The words “artificially sweetened” shall be of the same size and style of type as the word “lemonade”. (d) If an optional thickening or dispersing ingredient referred to in paragraph (a) of this section is used, the label shall bear the statement “______ added” or “with added ______”, the blank being filled in with the common name of the thickening or dispersing agent used. Such statement shall be set forth on the label with such prominence and conspicuousness as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase. (e) Frozen concentrate for artificially sweetened lemonade is labeled to conform to the labeling requirements prescribed for foods which purport to be or are represented for special dietary use by regulations promulgated pursuant to section 403(j) of the act. (f) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

21 C.F.R. § 146.126 Frozen concentrate for colored lemonade.

(a) Frozen concentrate for colored lemonade conforms to the definition and standard of identity prescribed for frozen concentrate for lemonade by § 146.120, except that it is colored with a safe and suitable fruit juice, vegetable juice, or any such juice in concentrated form, or with any other color additive ingredient suitable for use in food, including artificial coloring, used in conformity with regulations established pursuant to section 721 of the Federal Food, Drug, and Cosmetic Act. (b) The name of the food is “Frozen concentrate for ______ lemonade”, the blank being filled in with the word describing the color: for example, “Frozen concentrate for pink lemonade”. (c) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

21 C.F.R. § 146.132 Grapefruit juice.

(a) Identity—(1) Description. Grapefruit juice is the unfermented juice, intended for direct consumption, obtained by mechanical process from sound, mature grapefruit (Citrus paradisi Macfadyen) from which seeds and peel (except embryonic seeds and small fragments of seeds and peel which cannot be separated by good manufacturing practice) and excess pulp are removed and to which may be added not more than 10 percent by volume of the unfermented juice obtained from mature hybrids of grapefruit. The juice may be adjusted by the addition of the optional concentrated grapefruit juice ingredients specified in paragraph (a)(2) of this section, but the quantity of such concentrated grapefruit juice ingredient added shall not contribute more than 15 percent of the grapefruit juice soluble solids in the finished food. The grapefruit pulp, grapefruit oil, and grapefruit essence (components derived from grapefruit) content may be adjusted in accordance with good manufacturing practice. The juice may have been concentrated and later reconstituted with water suitable for the purpose of maintaining essential composition and quality factors of the juice. It may be sweetened with the dry nutritive sweeteners referred to in paragraph (a)(2)(iii) of this section. If the grapefruit juice is prepared from concentrate, such sweeteners, in liquid form, referred to in paragraph (a)(2)(iii) of this section, also may be used. When prepared from concentrated grapefruit juice, exclusive of added sweeteners, the finished food contains not less than 10 percent, by weight, of soluble solids taken as the refractometric sucrose value (of the filtrate), corrected to 20 °C, and corrected for acidity by adding (0.012 + 0.193x-0.0004x 2), where x equals the percent anhydrous citric acid in the sample, to the refractometrically obtained sucrose value by the first method prescribed in “Correction of Refractometer Sucrose Readings for Citric Acid Content for Lemonade,” by Yeatman, Senzel, and Springer, “Journal of the Association of Official Analytical Chemists,” vol. 59 p. 368 (1976). Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The food may contain one or any combination of the optional ingredients specified in paragraph (a)(2) of this section. Grapefruit juice, as defined in this paragraph, may be preserved by heat sterilization (canning), refrigeration, or freezing. When sealed in a container to be held at ambient temperatures, it is so processed by heat, before or after sealing, as to prevent spoilage. (2) Optional ingredients. The optional ingredients referred to in paragraph (a)(1) of this section are: (i) Concentrated grapefruit juice (grapefruit juice from which part of the water has been removed). (ii) Water and/or grapefruit juice to reconstitute concentrated grapefruit juice in the manufacture of grapefruit juice from concentrate. (iii) One or any combination of two or more of the dry or liquid forms of sugar, invert sugar sirup, dextrose, glucose sirup, and fructose. Sweeteners defined in part 168 of this chapter shall be as defined therein. (3) Labeling. (i) The name of the food is: (a) “Grapefruit juice” (1) if the food is prepared from unconcentrated, undiluted liquid extracted from mature grapefruit; or (2) if the food is prepared from unconcentrated, undiluted liquid extracted from mature grapefruit to which concentrated grapefruit juice is added to adjust soluble solids as provided for in paragraph (a)(1) of this section. (b) “Grapefruit juice from concentrate” (1) if the food is prepared from concentrated grapefruit juice and water and/or grapefruit juice; or (2) if the food is prepared from grapefruit juice from concentrate and grapefruit juice. The words “from concentrate” shall be shown in letters not less than one-half the height of the letters in the words “grapefruit juice.” (ii) If any nutritive sweetener is added, the principal display panel of the label shall bear the statement “Sweetener added.” If no sweetener is added, the word “unsweetened” may immediately precede or follow the words “Grapefruit Juice” or “Grapefruit Juice from Concentrate.” (iii) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter. (b) [Reserved] (c) Fill of container. (1) The standard of fill of container for grapefruit juice, except when the food is frozen, is not less than 90 percent of the total capacity of the container as determined by the general method for fill of container prescribed in § 130.12(b) of this chapter. (2) Compliance is determined as specified in § 146.3(g)(2). (3) If the grapefruit juice fails to meet the standard of fill as prescribed in paragraphs (c) (1) and (2) of this section, the label shall bear the general statement of substandard fill specified in § 130.14(b) of this chapter, in the manner and form therein prescribed.

21 C.F.R. § 146.135 Orange juice.

(a) Orange juice is the unfermented juice obtained from mature oranges of the species Citrus sinensis or of the citrus hybrid commonly called “Ambersweet” ( 1/2 Citrus sinensis X 3/8 Citrus reticulata X 1/8 Citrus paradisi (USDA Selection:1-100-29: 1972 Whitmore Foundation Farm)). Seeds (except embryonic seeds and small fragments of seeds that cannot be separated by current good manufacturing practice) and excess pulp are removed. The juice may be chilled, but it is not frozen. (b) The name of the food is “orange juice”. The name “orange juice” may be preceded on the label by the varietal name of the oranges used, and if the oranges grew in a single State, the name of such State may be included in the name, as for example, “California Valencia orange juice”.

21 C.F.R. § 146.137 Frozen orange juice.

(a) Frozen orange juice is orange juice as defined in § 146.135, except that it is frozen. (b) The name of the food is “Frozen orange juice”. Such name may be preceded on the label by the varietal name of the oranges used, and if the oranges grew in a single State, the name of such State may be included in the name, as for example, “California Valencia frozen orange juice”.

21 C.F.R. § 146.140 Pasteurized orange juice.

(a) Pasteurized orange juice is the food prepared from unfermented juice obtained from mature oranges as specified in § 146.135, to which may be added not more that 10 percent by volume of the unfermented juice obtained from mature oranges of the species Citrus reticulata or Citrus reticulata hybrids (except that this limitation shall not apply to the hybrid species described in § 146.135). Seeds (except embryonic seeds and small fragments of seeds that cannot be separated by good manufacturing practice) are removed, and pulp and orange oil may be adjusted in accordance with good manufacturing practice. If the adjustment involves the addition of pulp, then such pulp shall not be of the washed or spent type. The solids may be adjusted by the addition of one or more of the optional concentrated orange juice ingredients specified in paragraph (b) of this section. One or more of the optional sweetening ingredients listed in paragraph (c) of this section may be added in a quantity reasonably necessary to raise the Brix or the Brix-acid ratio to any point within the normal range usually found in unfermented juice obtained from mature oranges as specified in § 146.135. The orange juice is so treated by heat as to reduce substantially the enzymatic activity and the number of viable microorganisms. Either before or after such heat treatment, all or a part of the product may be frozen. The finished pasteurized orange juice contains not less than 10.5 percent by weight of orange juice soluble solids, exclusive of the solids of any added optional sweetening ingredients, and the ratio of the Brix hydrometer reading to the grams of anhydrous citric acid per 100 milliliters of juice is not less than 10 to 1. (b) The optional concentrated orange juice ingredients referred to in paragraph (a) of this section are frozen concentrated orange juice as specified in § 146.146 and concentrated orange juice for manufacturing as specified in § 146.153 when made from mature oranges; but the quantity of such concentrated orange juice ingredients added shall not contribute more than one-fourth of the total orange juice solids in the finished pasteurized orange juice. (c) The optional sweetening ingredients referred to in paragraph (a) of this section are sugar, invert sugar, dextrose, dried corn sirup, dried glucose sirup. (d)(1) The name of the food is “Pasteurized orange juice”. If the food is filled into containers and preserved by freezing, the label shall bear the name “Frozen pasteurized orange juice”. The words “pasteurized” or “frozen pasteurized” shall be shown on labels in letters not less than one-half the height of the letters in the words “orange juice”. (2) If the pasteurized orange juice is filled into containers and refrigerated, the label shall bear the name of the food, “chilled pasteurized orange juice”. If it does not purport to be either canned orange juice or frozen pasteurized orange juice, the word “chilled” may be omitted from the name. The words “pasteurized” or “chilled pasteurized” shall be shown in letters not less than one-half the height of the letters in the words “orange juice”. (e)(1) If a concentrated orange juice ingredient specified in paragraph (b) of this section is used in adjusting the orange juice solids of the pasteurized orange juice, the label shall bear the statement “prepared in part from concentrated orange juice” or “with added concentrated orange juice” or “concentrated orange juice added”. (2) If one or more of the sweetening ingredients specified in paragraph (c) of this section are added to the pasteurized orange juice, the label shall bear the statement “______ added”, the blank being filled in with the name or an appropriate combination of the names of the sweetening ingredients used. However, for the purpose of this section, the name “sweetener” may be used in lieu of the specific name or names of the sweetening ingredients. (f) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the statements specified in this section for naming the optional ingredients used shall immediately and conspicuously precede or follow the name of the food, without intervening written, printed, or graphic matter. (g) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

21 C.F.R. § 146.141 Canned orange juice.

(a) Canned orange juice is the food prepared from orange juice as specified in § 146.135 or frozen orange juice as specified in § 146.137, or a combination of both, to which may be added not more than 10 percent by volume of the unfermented juice obtained from mature oranges of the species Citrus reticulata or Citrus reticulata hybrids (except that this limitation shall not apply to the hybrid species described in § 146.135). Seeds (except embryonic seeds and small fragments of seeds that cannot be separated by good manufacturing practice) are removed. Orange oil and pulp may be adjusted in accordance with good manufacturing practice. The adjustment of pulp referred to in this paragraph does not permit the addition of washed or spent pulp. Liquid condensate recovered from the deoiling operation may be added back. One or more of the optional sweetening ingredients named in paragraph (b) of this section may be added, in a quantity reasonably necessary to raise the Brix or the Brix-acid ratio to any point within the normal range usually found in unfermented juice obtained from mature oranges as specified in § 146.135. The food is sealed in containers and so processed by heat, either before or after sealing, as to prevent spoilage. The finished canned orange juice tests not less than 10° Brix, and the ratio of the Brix hydrometer reading to the grams of anhydrous citric acid per 100 milliliters of juice is not less than 9 to 1. (b) The optional sweetening ingredients referred to in paragraph (a) of this section are sugar, invert sugar, dextrose, dried corn sirup, dried glucose sirup. (c) The name of the food is “Canned orange juice”. All the words in the name shall appear in the same size, color, and style of type and on the same color-contrasting background. If the food is not sold under refrigeration and if it does not purport to be chilled pasteurized orange juice or frozen pasteurized orange juice, the word “canned” may be omitted from the name. (d) If one or more of the sweetening ingredients specified in paragraph (b) of this section are added to the canned orange juice, the label shall bear the statement “______ added”, the blank being filled in with the name or an appropriate combination of the names of the sweetening ingredients used. However, for the purpose of this section, the name “sweetener” may be used in lieu of the specific name or names of the sweetening ingredients. (e) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the statement specified in this section for naming the optional ingredients used shall immediately and conspicuously precede or follow the name of the food, without intervening written, printed, or graphic matter. (f) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

21 C.F.R. § 146.145 Orange juice from concentrate.

(a) Orange juice from concentrate is the food prepared by mixing water with frozen concentrated orange juice as defined in § 146.146 or with concentrated orange juice for manufacturing as defined in § 146.153 (when made from mature oranges), or both. To such mixture may be added orange juice as defined in § 146.135, frozen orange juice as defined in § 146.137, pasteurized orange juice as defined in § 146.140, orange juice for manufacturing as defined in § 146.151 (when made from mature oranges and preserved by chilling or freezing but not by canning), orange oil, orange pulp, and one or more of the sweetening ingredients listed in paragraph (b) of this section. The finished orange juice from concentrate contains not less than 11.8 percent orange juice soluble solids, exclusive of solids of any added optional sweetening ingredients. It may be so treated by heat as to reduce substantially the enzymatic activity and the number of viable microorganisms. (b) The sweetening ingredients referred to in paragraph (a) of this section are sugar, sugar sirup, invert sugar, invert sugar sirup, dextrose, corn sirup, dried corn sirup, glucose sirup, dried glucose sirup. (c) The name of the food is “Orange juice from concentrate”. The words “from concentrate” shall be shown in letters not less than one-half the height of the letters in the words “orange juice”. (d) When orange juice from concentrate contains any optional sweetening ingredient as listed in paragraph (b) of this section, whether added directly as such or indirectly as an added ingredient of any orange juice product used, the label shall bear the statement “______ added”, the blank being filled in with the name or an appropriate combination of the names of the sweetening ingredients added. However, for the purposes of this section the name “sweetener” may be used in lieu of the specific name or names of the sweetening ingredients. (e) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the statements specified in this section for naming the optional ingredients used shall immediately and conspicuously precede or follow the name of the food, without intervening written, printed, or graphic matter. (f) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

21 C.F.R. § 146.146 Frozen concentrated orange juice.

(a) Frozen concentrated orange juice is the food prepared by removing water from the juice of mature oranges as provided in § 146.135, to which may be added unfermented juice obtained from mature oranges of the species Citrus reticulata, other Citrus reticulata hybrids, or of Citrus aurantium, or both. However, in the unconcentrated blend, the volume of juice from Citrus reticulata or Citrus reticulata hybrids shall not exceed 10 percent (except that this limitation shall not apply to the hybrid species described in § 146.135) and from Citrus aurantium shall not exceed 5 percent. The concentrate so obtained is frozen. In its preparation, seeds (except embryonic seeds and small fragments of seeds that cannot be separated by good manufacturing practice) and excess pulp are removed, and a properly prepared water extract of the excess pulp so removed may be added. Orange oil, orange pulp, orange essence (obtained from orange juice), orange juice and other orange juice concentrate as provided in this section or concentrated orange juice for manufacturing provided in § 146.153 (when made from mature oranges), water, and one or more of the optional sweetening ingredients specified in paragraph (b) of this section may be added to adjust the final composition. The juice of Citrus reticulata and Citrus aurantium, as permitted by this paragraph, may be added in single strength or concentrated form prior to concentration of the Citrus sinensis juice, or in concentrated form during adjustment of the composition of the finished food. The addition of concentrated juice from Citrus reticulata or Citrus aurantium, or both, shall not exceed, on a single-strength basis, the 10 percent maximum for Citrus reticulata and the 5 percent maximum for Citrus aurantium prescribed by this paragraph. Any of the ingredients of the finished concentrate may have been so treated by heat as to reduce substantially the enzymatic activity and the number of viable microorganisms. The finished food is of such concentration that when diluted according to label directions the diluted article will contain not less than 11.8 percent by weight of orange juice soluble solids, exclusive of the solids of any added optional sweetening ingredients. The dilution ratio shall be not less than 3 plus 1. For the purposes of this section and § 146.150, the term “dilution ratio” means the whole number of volumes of water per volume of frozen concentrate required to produce orange juice from concentrate having orange juice soluble solids of not less than 11.8 percent by weight exclusive of the solids of any added optional sweetening ingredients. (b) The optional sweetening ingredients referred to in paragraph (a) of this section are sugar, sugar sirup, invert sugar, invert sugar sirup, dextrose, corn sirup, dried corn sirup, glucose sirup, and dried glucose sirup. (c) If one or more of the sweetening ingredients specified in paragraph (b) of this section are added to the frozen concentrated orange juice, the label shall bear the statement “______ added”, the blank being filled in with the name or an appropriate combination of names of the sweetening ingredients used. However, for the purpose of this section, the name “sweetener” may be used in lieu of the specific name or names of the sweetening ingredients. (d) The name of the food concentrated to a dilution ratio of 3 plus 1 is “frozen concentrated orange juice” or “frozen orange juice concentrate”. The name of the food concentrated to a dilution ratio greater than 3 plus 1 is “frozen concentrated orange juice, ______ plus 1” or “frozen orange juice concentrate, ______ plus 1”, the blank being filled in with the whole number showing the dilution ratio; for example, “frozen orange juice concentrate, 4 plus 1”. However, where the label bears directions for making 1 quart of orange juice from concentrate (or multiples of a quart), the blank in the name may be filled in with a mixed number; for example, “frozen orange juice concentrate, 4 1/3 plus 1”. For containers larger than 1 pint, the dilution ratio in the name may be replaced by the concentration of orange juice soluble solids in degrees Brix; for example, a 62° Brix concentrate in 3 1/2-gallon cans may be named on the label “frozen concentrated orange juice, 62° Brix”. (e) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the statements specified in this section for naming the optional ingredients used shall immediately and conspicuously precede or follow the name of the food, without intervening written, printed, or graphic matter. (f) Nothing in this section is intended to interfere with the adoption and enforcement by any State, in regulating the production of frozen concentrated orange juice in such State, of State standards, consistent with this section, but which impose higher or more restrictive requirements than those set forth in this section. (g) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

21 C.F.R. § 146.148 Reduced acid frozen concentrated orange juice.

(a) Reduced acid frozen concentrated orange juice is the food that complies with the requirements for composition and label declaration of ingredients prescribed for frozen concentrated orange juice by § 146.146, except that it may not contain any added sweetening ingredient. A process involving the use of anionic ion-exchange resins permitted by § 173.25 of this chapter is used to reduce the acidity of the food so that the ratio of the Brix reading to the grams of acid, expressed as anhydrous citric acid, per 100 grams of juice is not less than 21 to 1 or more than 26 to 1. (b) The name of the food is “Reduced acid frozen concentrated orange juice”.

21 C.F.R. § 146.150 Canned concentrated orange juice.

(a) Canned concentrated orange juice is the food that complies with the requirements of composition, definition of dilution ratio, and labeling of ingredients prescribed for frozen concentrated orange juice by § 146.146, except that it is not frozen and it is sealed in containers and so processed by heat, either before or after sealing, so as to prevent spoilage. (b) The name of the food when concentrated to a dilution ratio of 3 plus 1 is “Canned concentrated orange juice” or “Canned orange juice concentrate”. The name of the food when concentrated to a dilution ratio greater than 3 plus 1 is “Canned concentrated orange juice, ______ plus 1” or “Canned orange juice concentrate, ______ plus 1”, the blank being filled in with the whole number showing the dilution ratio; for example, “Canned orange juice concentrate, 4 plus 1”. However, where the label bears directions for making 1 quart of single-strength diluted product (or multiples of a quart) the blank in the name may be filled in with a mixed number; for example, “Canned orange juice concentrate, 4 1/3 plus 1”. For containers larger than 1 pint, the dilution ratio in the name may be replaced by the concentration of orange juice soluble solids in degrees Brix; for example, a 62° Brix concentrate in 1-gallon cans may be named on the label “canned concentrated orange juice, 62° Brix”. If the food does not purport to be frozen concentrated orange juice, the word “canned” may be omitted from the name.

21 C.F.R. § 146.151 Orange juice for manufacturing.

(a) Orange juice for manufacturing is the food prepared for further manufacturing use. It is prepared from unfermented juice obtained from oranges as provided in § 146.135, except that the oranges may deviate from the standards for maturity in that they are below the minimum for Brix and Brix-acid ratio for such oranges, and to which juice may be added not more than 10 percent by volume of the unfermented juice obtained from oranges of the species Citrus reticulata or Citrus reticulata hybrids (except that this limitation shall not apply to the hybrid species described in § 146.135). Seeds (except embryonic seeds and small fragments of seeds that cannot be separated by good manufacturing practice) are removed, and pulp and orange oil may be adjusted in accordance with good manufacturing practice. If pulp is added it shall be other than washed or spent pulp. The juice or portions thereof may be so treated by heat as to reduce substantially the enzymatic activity and number of viable microorganisms, and it may be chilled or frozen, or it may be so treated by heat, either before or after sealing in containers, as to prevent spoilage. (b) The name of the food is “Orange juice for manufacturing”.

21 C.F.R. § 146.152 Orange juice with preservative.

(a) Orange juice with preservative is the food prepared for further manufacturing use. It complies with the requirements for composition of orange juice for manufacturing as provided for in § 146.151, except that a preservative is added to inhibit spoilage. It may be heat-treated to reduce substantially the enzymatic activity and the number of viable microorganisms. (b) The preservatives referred to in paragraph (a) of this section are any safe and suitable preservatives or combinations thereof. (c) The name of the food is “Orange juice with preservative”. (d) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter. In addition, the name of each preservative shall be proceeded by a statement of the percent by weight of the preservative used. If the food is packed in container sizes that are less than 19 liters (5 gallons), the label shall bear a statement indicating that the food is for further manufacturing use only. (e) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the statement specified in paragraph (d) of this section for naming the preservative ingredient used shall immediately and conspicuously precede or follow the name of the food, without intervening written, printed, or graphic matter.

21 C.F.R. § 146.153 Concentrated orange juice for manufacturing.

(a) Concentrated orange juice for manufacturing is the food that complies with the requirements of composition and label declaration of ingredients prescribed for frozen concentrated orange juice by § 146.146, except that it is either not frozen or is less concentrated, or both, and the oranges from which the juice is obtained may deviate from the standards for maturity in that they are below the minimum Brix and Brix-acid ratio for such oranges: Provided, however, that the concentration of orange juice soluble solids is not less than 20° Brix. (b) The name of the food is “Concentrated orange juice for manufacturing, ______” or “______ orange juice concentrate for manufacturing”, the blank being filled in with the figure showing the concentration of orange juice soluble solids in degrees Brix.

21 C.F.R. § 146.154 Concentrated orange juice with preservative.

(a) Concentrated orange juice with preservative complies with the requirements for composition and labeling of optional ingredients prescribed for concentrated orange juice for manufacturing by § 146.153, except that a preservative is added to inhibit spoilage. (b) The preservatives referred to in paragraph (a) of this section are any safe and suitable preservatives or combinations thereof. (c) The name of the food is “Concentrated orange juice with preservative, ______”, the blank being filled in with the figure showing the concentration of orange juice soluble solids in degrees Brix. (d) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter. In addition, the name of each preservative shall be preceded by a statement of the percent by weight of the preservative used. If the food is packed in container sizes that are less than 19 liters (5 gallons), the label shall bear a statement indicating that the food is for further manufacturing use only. (e) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the statement specified in paragraph (d) of this section for naming the preservative ingredient used shall immediately and conspicuously precede or follow the name of the food, without intervening written, printed, or graphic matter.

21 C.F.R. § 146.185 Pineapple juice.

(a) Identity. (1) Pineapple juice is the juice, intended for direct consumption, obtained by mechanical process from the flesh or parts thereof, with or without core material, of sound, ripe pineapple (Ananas comosus L. Merrill). The juice may have been concentrated and later reconstituted with water suitable for the purpose of maintaining essential composition and quality factors of the juice. Pineapple juice may contain finely divided insoluble solids, but it does not contain pieces of shell, seeds, or other coarse or hard substances or excess pulp. It may be sweetened with any safe and suitable dry nutritive carbohydrate sweetener. However, if the pineapple juice is prepared from concentrate, such sweeteners, in liquid form, also may be used. It may contain added vitamin C in a quantity such that the total vitamin C in each 4 fluid ounces of the finished food amounts to not less than 30 milligrams and not more than 60 milligrams. In the processing of pineapple juice, dimethylpolysiloxane complying with the requirements of § 173.340 of this chapter may be employed as a defoaming agent in an amount not greater than 10 parts per million by weight of the finished food. Such food is prepared by heat sterilization, refrigeration, or freezing. When sealed in a container to be held at ambient temperatures, it is so processed by heat, before or after sealing, as to prevent spoilage. (2) The name of the food is “Pineapple juice” if the juice from which it is prepared has not been concentrated and/or diluted with water. The name of the food is “Pineapple juice from concentrate” if the finished juice has been made from pineapple juice concentrate as specified in paragraph (a) of this section. If a nutritive sweetener is added, the label shall bear the statement “Sweetener added.” If no sweetener is added, the word “Unsweetened” may immediately precede or follow the words “Pineapple juice” or “Pineapple juice from concentrate.” (3) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter. (b) Quality. (1) The standard of quality for pineapple juice is as follows: (i) The soluble solids content of pineapple juice (exclusive of added sugars) without added water shall not be less than 10.5° Brix as determined by refractometer at 20 °C uncorrected for acidity and read as degrees Brix on International Sucrose Scales. Where the juice has been obtained using concentrated juice with addition of water, the soluble pineapple juice solids content (exclusive of added sugars) shall be not less than 12.8° Brix, uncorrected for acidity and read as degrees Brix on the International Sucrose Scales. (ii) The acidity, as determined by the method prescribed in paragraph (b)(2)(ii) of this section, is not more than 1.35 grams of anhydrous citric acid per 100 milliliters of the juice. (iii) The ratio of the degrees Brix to total acidity, as determined by the method prescribed in paragraph (b)(2)(iii) of this section, is not less than 12. (iv) The quantity of finely divided “insoluble solids”, as determined by the method prescribed in paragraph (b)(2)(iv) of this section, is not less than 5 percent nor more than 30 percent. (2) The methods referred to in paragraph (b)(1) of this section are as follows: (i) Determine the degrees Brix of the pineapple juice by the method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), section 31.009, “Solids by Means of Spindle—Official Final Action,” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (ii) Determine the total acidity of the pineapple juice by titration by the method prescribed in § 145.180(b)(2)(ix) of this chapter. (iii) Divide the degrees Brix determined as prescribed in paragraph (b)(2)(i) of this section by the grams of anhydrous citric acid per 100 milliliters of juice, determined as prescribed in paragraph (b)(2)(ii) of this section, and report the results as ratio of degrees Brix to total acidity. (iv) Determine the quantity of “insoluble solids” in pineapple juice as follows: Measure 50 milliliters of thoroughly stirred pineapple juice into a cone-shaped graduated tube of the long-cone type, measuring approximately 4 3/16 inches from tip to top calibration and having a capacity of 50 milliliters. Place the tube in a suitable centrifuge the approximate speed of which is related to diameter of swing in accordance with the table immediately below. The word “diameter” means the over-all distance between the tips of opposing centrifuge tubes in operating position. (3) If the quality of pineapple juice falls below the standard prescribed in paragraph (b)(1) of this section, the label shall bear the general statement of substandard quality specified in § 130.14 (a) of this chapter, in the manner and form therein specified. (c) Fill of container. (1) The standard of fill of container for pineapple juice, except when the food is frozen, is not less than 90 percent of the total capacity of the container, as determined by the general method for fill of container prescribed in § 130.12(b) of this chapter. (2) If pineapple juice falls below the standard of fill of container prescribed in paragraph (c)(1) of this section, the label shall bear the statement of substandard fill specified in § 130.14(b) of this chapter, in the manner and form therein specified.

21 C.F.R. § 146.187 Canned prune juice.

(a) Canned prune juice is the food prepared from a water extract of dried prunes and contains not less than 18.5 percent by weight of water-soluble solids extracted from dried prunes. The quantity of prune solids may be adjusted by the concentration, dilution, or both, of the water extract or extracts made. Such food may contain one or more of the optional acidifying ingredients specified in paragraph (b)(1) of this section, in a quantity sufficient to render the food slightly tart; it may contain honey added within the quantitative limits prescribed by paragraph (b)(2) of this section; and it may contain added vitamin C in a quantity prescribed by paragraph (b)(3) of this section. Such food is sealed in a container and so processed by heat, before or after sealing, as to prevent spoilage. (b) The optional ingredients referred to in paragraph (a) of this section are: (1) One or any combination of two or more of the following acidifying ingredients: (i) Lemon juice. (ii) Lime juice. (iii) Citric acid. (2) Honey, in a quantity not less than 2 percent and not more than 3 percent by weight of the finished food. (3) Vitamin C, in a quantity such that the total vitamin C in each 6 fluid ounces of the finished food amounts to not less than 30 milligrams and not more than 50 milligrams. (c)(1) The name of the food is “Prune juice—a water extract of dried prunes”. For the purposes of the Federal Food, Drug, and Cosmetic Act concerning the label declaration of the name of the food, the explanatory statement “A water extract of dried prunes” may appear immediately below the words “prune juice”, but there shall be no intervening written, printed, or graphic matter, and the type used for the words “A water extract of dried prunes” shall be of the same style and not less than half the print size of the type used for the words “prune juice”. (2)(i) When one or more of the acidifying ingredients specified in paragraph (b)(1) of this section are used, the label shall bear the statement “______ added” or “with added ______”, the blank being filled in with the name or names of the optional ingredients used. (ii) When honey, as specified in paragraph (b)(2) of this section, is used the label shall bear the statement “with ______ honey” or “______ honey added”, the blank to be filled in with the percent by weight of the honey in the finished food or with the statement “between 2 and 3%”. (iii) When one or more of the ingredients designated in paragraph (b)(1) of this section and the ingredient designated in paragraph (b)(2) of this section are used, the statements specified in paragraphs (c)(2) (i) and (ii) of this section may be combined, as for example, “with lemon juice and between 2 and 3% honey added”. (iv) When vitamin C is added as provided in paragraph (b)(3) of this section, it shall be designated on the label as “vitamin C added” or “with added vitamin C”. (3) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the words specified in this paragraph, showing the optional ingredients used, shall immediately and conspicuously precede or follow such name, without intervening written, printed, or graphic matter. (d) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

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