[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2011] [CITE: 21CFR150] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION PART 150 FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS Subpart B--Requirements for Specific Standardized Fruit Butters, Jellies, Preserves, and Related Products Sec. 150.110 Fruit butter. (a) The fruit butters for which definitions and standards of identity are prescribed by this section are the smooth, semisolid foods each of which is made from a mixture of one or a permitted combination of the optional fruit ingredients specified in paragraph (b) of this section and one or any combination of the optional ingredients specified in paragraph (c) of this section, which meets the specifications in paragraph (d) of this section, and which is labeled in accordance with paragraph (e) of this section. Such mixture is concentrated with or without heat. The volatile flavoring materials or essence from such mixture may be captured during concentration, separately concentrated, and added back to any such mixture, together with any concentrated essence accompanying any optional fruit ingredient. (b)(1) Each of the optional fruit ingredients referred to in paragraph (a) of this section is prepared by cooking one of the following fresh, frozen, canned, and/or dried (evaporated) mature fruits, with or without added water, and screening out skins, seeds, pits, and cores: Factor Referred to in Paragraph (d)(2) of This Section Name of fruit Apple 7.5 Apricot 7.0 Grape 7.0 Peach 8.5 Pear 6.5 Plum (other than prune) 7.0 Prune 7.0 Quince 7.5 (2) The permitted combinations are of two, three, four, and five of the fruit ingredients specified in paragraph (b)(1) of this section; the weight of each is not less than one-fifth of the weight of the combination. Each 1 such fruit ingredient in any such combination is an optional ingredient. (c) The following safe and suitable optional ingredients may be used: (1) Nutritive carbohydrate sweeteners. (2) Spice. (3) Flavoring (other than artificial flavoring). (4) Salt. (5) Acidifying agents. (6) Fruit juice or diluted fruit juice or concentrated fruit juice, in a quantity not less than one-half the weight of the optional fruit ingredient. (7) Preservatives. (8) Antifoaming agents except those derived from animal fats. (9) Pectin, in a quantity which reasonably compensates for deficiency, if any, of the natural pectin content of the fruit ingredient. (d) For the purposes of this section: (1) The mixture referred to in paragraph (a) of this section shall contain not less than five parts by weight of the fruit ingredient as measured in accordance with paragraph (d)(2) of this section to each two parts by weight of nutritive carbohydrate sweetener as measured in accordance with paragraph (d)(4) of this section. (2) Any requirement with respect to the weight of any optional fruit ingredient, whether concentrated, unconcentrated, or diluted, means the weight determined by the following method: (i) Determine the percent of soluble solids in the optional fruit ingredient by the method for soluble solids referred to in paragraph (d)(3) of this section; (ii) multiply the percent so found by the weight of such fruit ingredient; (iii) divide the result by 100; (iv) subtract from the quotient the weight of any nutritive sweetener solids or other added solids; and (v) multiply the remainder by the factor for such ingredient prescribed in paragraph (b)(1) of this section. The result is the weight of the optional fruit ingredient. (3) The soluble solids content of the finished fruit butter is not less than 43 percent, as determined by the method prescribed in "Official Methods of Analysis of the Association of Official Analytical Chemists" (AOAC), 13th Ed. (1980), section 22.024, under "Soluble Solids by Refractometer in Fresh and Canned Fruits, Fruit Jellies, Marmalades, and Preserves--Official Final Action," which is incorporated by reference, except that no correction is made for water-insoluble solids. 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 2 material at NARA, call 202-741-6030, or go http://www.archives.gov/federal_register/code_of_federal_regulations/ibr to: _locations.html. (4) The weight of any nutritive carbohydrate sweetener means the weight of the solids of such ingredient. (5) The weight of fruit juice or diluted fruit juice or concentrated fruit juice (optional ingredient, paragraph (c)(6)) from a fruit specified in paragraph (b)(1) of this section is the weight of such juice, as determined by the method prescribed in paragraph (d)(2) of this section, except that the percent of soluble solids is determined by the method prescribed in the AOAC, 13th Ed. (1980), section 31.011, under "Solids by Means of Refractometer--Official Final Action," which is incorporated by reference; the weight of diluted concentrated juice from any other fruits is the original weight of the juice before it was diluted or concentrated. The availability of this incorporation by reference is given in paragraph (d)(3) of this section. Label declaration. (e)(1) 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, except that: (i) In case the fruit butter is made from a single fruit ingredient, the name is "Butter", preceded by the name where by such fruit is designated in paragraph (b)(1) of this section. (ii) In case the fruit butter is made from a combination of two, three, four, or five fruit ingredients, the name is "Butter", preceded by the words "Mixed fruit" or by the names whereby such fruits are designated in paragraph (b)(1) of this section, in the order of predominance, if any, of the weight of such fruit ingredients in the combination. (2) Each of the optional ingredients specified in paragraphs (b) and (c) of this section shall be declared on the label as required by the applicable sections of part 101 of this chapter, except that: (i) Other than in the case of dried (evaporated) fruit the name(s) of the fruit or fruits used may be declared without specifying the particular form of the fruit or fruits used. When the optional fruit ingredient is prepared in whole or in part from dried fruit, the label shall bear the words "prepared from" or "prepared in part from", as the case may be, followed by the word "evaporated" or "dried", followed by the name whereby such fruit is designated in paragraph (c) of this section. When two or more such optional fruit ingredients are used, such names, each preceded by the word "evaporated" or "dried", shall appear in the order of predominance, if any, of the weight of such ingredients in the combination. (ii) [Reserved] [42 FR 14445, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19, 1982; 49 FR 10101, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2882, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] 3 Sec. 150.140 Fruit jelly. (a) The jellies for which definitions and standards of identity are prescribed by this section are the jelled foods each of which is made from a mixture of one or a permitted combination of the fruit juice ingredients specified in paragraph (b) of this section and one or any combination of the optional ingredients specified in paragraph (c) of this section, which meets the specifications in paragraph (d) of this section and which is labeled in accordance with paragraph (e) of this section. Such mixture is concentrated with or without heat. The volatile flavoring materials or essence from such mixture may be captured during concentration, separately concentrated, and added back to any such mixture, together with any concentrated essence accompanying any optional fruit ingredient. (b)(1) Each of the fruit juice ingredients referred to in paragraph (a) of this section is the filtered or strained liquid extracted with or without the application of heat and with or without the addition of water, from one of the following mature, properly prepared fruits which are fresh, frozen and/or canned: Factor Referred to in Paragraph (d)(2) of This Section Name of fruit Apple 7.5 Apricot 7.0 Blackberry (other than dewberry) 10.0 Black raspberry 9.0 Boysenberry 10.0 Cherry 7.0 Crabapple 6.5 Cranberry 9.5 Damson, damson plum 7.0 Dewberry (other than boysenberry, loganberry, and youngberry) 10.0 Fig 5.5 Gooseberry 12.0 Grape 7.0 Grapefruit 11.0 Greengage, greengage plum 7.0 Guava 13.0 Loganberry 9.5 Orange 8.0 Peach 8.5 Pineapple 7.0 Plum (other than damson, greengage, and prune) 7.0 4 Pomegranate 5.5 Prickly pear 11.0 Quince 7.5 Raspberry, red raspberry 9.5 Red currant, currant (other than black currant) 9.5 Strawberry 12.5 Youngberry 10.0 (2) The permitted combinations are of two, three, four, or five of the fruit juice ingredients specified in paragraph (b)(1) of this section, the weight of each is not less than one-fifth of the weight of the combination. Each such fruit juice ingredient in any such combination is an optional ingredient. (c) The following safe and suitable optional ingredients may be used: (1) Nutritive carbohydrate sweeteners. (2) Spice. (3) Acidifying agents. (4) Pectin, in a quantity which reasonably compensates for deficiency, if any, of the natural pectin content of the fruit juice ingredient. (5) Buffering agents. (6) Preservatives. (7) Antifoaming agents except those derived from animal fats. (8) Mint flavoring and artificial green coloring, in case the fruit juice ingredient or combination of fruit juice ingredients is extracted from apple, crabapple, pineapple, or two or all of such fruits. (9) Cinnamon flavoring, other than artificial flavoring, and artificial red coloring in case the fruit juice ingredient or combination of fruit juice ingredients is extracted from apple or crabapple or both such fruits. (d) For the purposes of this section: (1) The mixture referred to in paragraph (a) of this section shall contain not less than 45 parts by weight of the fruit juice ingredients as measured in accordance with paragraph (d)(2) of this section to each 55 parts by weight of saccharine ingredient as measured in accordance with paragraph (d)(4) of this section. (2) Any requirement with respect to the weight of any fruit juice ingredient, whether prepared from concentrated, unconcentrated, or diluted fruit juice means the weight determined by the following method: (i) 5 Determine the percent of soluble solids in such fruit juice ingredient by the method for soluble solids referred to in paragraph (d)(3) of this section; (ii) multiply the percent so found by the weight of such fruit juice ingredient; (iii) divide the result by 100; (iv) subtract from the quotient the weight of any added saccharine ingredient solids or other added solids; and (v) multiply the remainder by the factor for such fruit juice ingredient prescribed in paragraph (b) of this section. The result is the weight of the fruit juice ingredient. (3) The soluble-solids content of the finished jelly is not less than 65 percent, as determined by the method prescribed in "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), section 31.011, under "Solids by Means of Refractometer--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 http://www.archives.gov/federal_register/code_of_federal_regulations/ibr to: _locations.html. (4) The weight of any optional saccharine ingredient means the weight of the solids of such ingredient. (e)(1) The name of each jelly for which a definition and standard of identity is prescribed by this section is as follows: (i) In case the jelly is made with a single fruit juice ingredient, the name is "Jelly", preceded or followed by the name or synonym whereby the fruit from which such fruit juice ingredient was extracted is designated in paragraph (b) of this section. (ii) In case the jelly is made with a combination of two, three, four, or five fruit juice ingredients, the name is "Jelly", preceded or followed by the words "Mixed fruit" or by the names or synonyms whereby the fruits from which the fruit juice ingredients were extracted are designated in paragraph (b) of this section, in the order of predominance, if any, of the weights of any such fruit juice ingredients in the combination. Label declaration. (2) 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, except that: (i) The name(s) of the fruit or fruits used may be declared without specifying the particular form of the fruit or fruits used. (ii) When the optional ingredients listed in paragraphs (c) (3), (4), and (5) of this section are declared on the label, the declaration may be followed by the statement "Used as needed" on all jellies to which they are customarily, but not always, added to compensate for natural variations in the fruit juice ingredients used. [42 FR 14445, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19, 1982; 49 FR 10101, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2882, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] 6 Sec. 150.141 Artificially sweetened fruit jelly. (a) The artificially sweetened fruit jellies for which definitions and standards of identity are prescribed by this section are the jellied foods made from a fruit juice ingredient as specified in paragraph (b) of this section and an artificial sweetening ingredient as specified in paragraph (c) of this section, with a jelling ingredient as specified in paragraph (d) of this section. Water may be added. The quantity of the fruit juice ingredient, calculated as set out in 150.140(b), amounts to not less than 55 percent by weight of the finished food. The article is sealed in containers and so processed by heat, either before or after sealing, as to prevent spoilage. Such food may also contain one or more of the following optional ingredients: (1) Spice, spice oil, spice extract. (2) A vinegar, lemon juice, lime juice, citric acid, lactic acid, malic acid, tartaric acid, fumaric acid, or any combination of two or more of these, in a quantity which reasonably compensates for deficiency, if any, of the natural acidity of the fruit juice ingredient. (3) Sodium citrate, sodium acetate, sodium tartrate, monosodium phosphate, disodium phosphate, trisodium phosphate, sodium potassium tartrate, potassium citrate, potassium acid tartrate, or any combination thereof, in an amount not exceeding 2 ounces avoirdupois per 100 pounds of the finished food. (4) Sodium hexametaphosphate in an amount not exceeding 8 ounces avoirdupois per 100 pounds of the finished food. (5) Purified calcium chloride, calcium citrate, calcium gluconate, calcium lactate, calcium sulfate, monocalcium phosphate, potassium chloride, or any combination of two or more of these salts, in a quantity reasonably necessary to enable the jelling ingredients to produce a jellied finished product. (6) Ascorbic acid, sorbic acid, sodium sorbate, potassium sorbate, sodium propionate, calcium propionate, sodium benzoate, benzoic acid, p- p- methylparaben (methyl- hydroxybenzoate), propylparaben (propyl- hydroxybenzoate), or any combination of two or more of these, in a quantity reasonably necessary as a preservative, but not to exceed 0.1 percent by weight of the finished food. (b) The fruit juice ingredient referred to in paragraph (a) of this section is any one, or any combination of two, three, four, or five of the fruit juice ingredients complying with the requirements of 150.140(c). Except as paragraph (d) of this section permits the use of pectin, carrageenan, or salts of carrageenan standardized with nutritive sweetener, no nutritive sweetening ingredient is added, either directly or indirectly, to the fruit juice ingredient used to make artificially sweetened fruit jelly. (c) The artificial sweetening ingredients referred to in paragraph (a) of this section are saccharin, sodium saccharin, calcium saccharin, or any combination of two or more of these. 7 (d) The jelling ingredients referred to in paragraph (a) of this section are pectin, agar-agar, carob bean gum (also called locust bean gum), guar gum, gum karaya, gum tragacanth, algin (sodium alginate), sodium carboxymethylcellulose (cellulose gum), methylcellulose (meeting U.S.P. requirements and with methoxy content not less than 27.5 percent and not more than 31.5 percent on a dry-weight basis), carrageenan or salts of carrageenan complying with the requirements of 172.620 or 172.626 of this chapter, or any combination of two or more of these. Pectin may be standardized with a nutritive sweetening ingredient, but such sweetening ingredient shall not amount to more than 44 percent by weight of the standardized pectin and the quantity of such standardized pectin used shall not exceed 3 percent by weight of the finished food. Carrageenan or salts of carrageenan may be standardized with a nutritive sweetening ingredient, but such sweetening ingredient shall not amount to more than 25 percent by weight of the standardized carrageenan or salts of carrageenan and the quantity of such standardized carrageenan or salts of carrageenan used shall not exceed 2 percent by weight of the finished food. (e) The name of each artificially sweetened fruit jelly for which a definition and standard of identity is prescribed by this section consists of the words "artificially sweetened", immediately followed by the name prescribed by 150.140(e)(1) for the fruit jelly which corresponds in its fruit ingredient to the artificially sweetened article. The words "artificially sweetened" shall be prominently and conspicuously displayed in letters not smaller than the largest letter used in any other word in the name of the food. (f)(1) The jelling ingredient used shall be named on the label by a statement "___ added" or "with added ___", the blank being filled in with the common name of the jelling ingredient used; for example, "pectin and methylcellulose added". (2) When one of the optional ingredients specified in paragraph (a)(1) of this section is used, the label shall bear the statement "___ added" or "with added ___", the blank being filled in with the words "spice", "spice oil", or "spice extract" as appropriate, but in lieu of the word "spice" in such statement the common name of the spice may be used. (3) When the optional ingredient specified in paragraph (a)(4) of this section is used, the label shall bear the words "sodium hexametaphosphate added" or "with added sodium hexametaphosphate". (4) When any optional ingredient listed in paragraph (a)(6) of this section is used, the label shall bear the statement "___ added as a preservative", the blank being filled in with the common name of the preservative ingredient used as designated in paragraph (a)(6) of this section. (g) Wherever the name of the food appears on the label of the artificially sweetened fruit jelly so conspicuously as to be easily seen under customary conditions of purchase, the words and statements specified in this section, showing the optional ingredients used, shall immediately and conspicuously precede or follow such name, without intervening written, printed, or graphic matter, except that the varietal name of the fruit source of the fruit juice ingredient used in preparing such jelly may so intervene. 8 Label declaration. (h) 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. [42 FR 14445, Mar. 15, 1977, as amended at 58 FR 2882, Jan. 6, 1993] Sec. 150.160 Fruit preserves and jams. (a) The preserves or jams for which definitions and standards of identity are prescribed by this section are the viscous or semi-solid foods, each of which is made from a mixture composed of one or a permitted combination of the fruit ingredients specified in paragraph (b) of this section and one or any combination of the optional ingredients specified in paragraph (c) of this section which meets the specifications in paragraph (d) of this section, and which is labeled in accordance with paragraph (e) of this section. Such mixture, with or without added water, is concentrated with or without heat. The volatile flavoring material from such mixture may be captured during concentration, separately concentrated, and added back to any such mixture, together with any concentrated essence accompanying any optional fruit ingredient. (b)(1) The fruit ingredients referred to in paragraph (a) of this section are the following mature, properly prepared fruits which are fresh, concentrated, frozen and/or canned: Group I Blackberry (other than dewberry), Black raspberry, Blueberry, Boysenberry, Cherry, Crabapple, Dewberry (other than boysenberry, loganberry, and youngberry) Elderberry, Grape, Grapefruit, Huckleberry, Loganberry, Orange, Pineapple, Raspberry, red raspberry, Rhubarb, Strawberry, Tangerine, Tomato, Yellow tomato, Youngberry Group II Apricot, Cranberry, Damson, damson plum, Fig, Gooseberry, Greengage, greengage plum, Guava, Nectarine, Peach, Pear, Plum (other than greengage plum and damson plum), Quince, Red currant, currant (other than black currant) (2) The following combinations of fruit ingredients may be used: (i) Any combination of two, three, four, or five of such fruits in which the weight of each is not less than one-fifth of the weight of the combination; except that the weight of pineapple may be not less than one- tenth of the weight of the combination. 9 (ii) Any combination of apple and one, two, three, or four of such fruits in which the weight of each is not less than one-fifth and the weight of apple is not more than one-half of the weight of the combination; except that the weight of pineapple may be not less than one-tenth of the weight of the combination. In any combination of two, three, four, or five fruits, each such fruit is an optional ingredient. For the purposes of this section the word "fruit" includes the vegetables specified in this paragraph. (c) The following safe and suitable optional ingredients may be used: (1) Nutritive carbohydrate sweeteners. (2) Spice. (3) Acidifying agents. (4) Pectin, in a quantity which reasonably compensates for deficiency, if any, of the natural pectin content of the fruit ingredient. (5) Buffering agents. (6) Preservatives. (7) Antifoaming agents, except those derived from animal fat. (d) For the purposes of this section: (1) The mixture referred to in paragraph (a) of this section shall be composed of not less than: (i) In the case of a fruit ingredient consisting of a Group I fruit or a permitted combination exclusively of Group I fruits, 47 parts by weight of the fruit ingredient to each 55 parts by weight of the saccharine ingredient; and (ii) in all other cases, 45 parts by weight of the fruit ingredient to each 55 parts by weight of the saccharine ingredient. The weight of the fruit ingredient shall be determined in accordance with paragraph (d)(2) of this section, and the weight of the saccharine ingredient shall be determined in accordance with paragraph (d)(5) of this section. (2) Any requirement with respect to the weight of any fruit, combination of fruits, or fruit ingredient means: (i) The weight of fruit exclusive of the weight of any sugar, water, or other substance added for any processing or packing or canning, or otherwise added to such fruit. (ii) In the case of fruit prepared by the removal, in whole or in part, of pits, seeds, skins, cores, or other parts; the weight of such fruit, exclusive of the weight of all such substances removed therefrom. (iii) In the cases of apricots, cherries, grapes, nectarines, peaches, and all varieties of plums, whether or not pits and seeds are removed therefrom; the weight of such fruit, exclusive of the weight of such pits 10