Macaroni and noodle products (21 CFR 139.110-139.180)

543 Food and Drug Administration, HHS § 139.110 taken disposing of the objections, after pub lic hearing thereon. [42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19, 1982; 49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, Jan. 6, 1993; 61 FR 8796, Mar. 5, 1996] PART 139—MACARONI AND NOODLE PRODUCTS Subpart A [Reserved] Subpart B—Requirements for Specific Standardized Macaroni and Noodle Products Sec. 139.110 Macaroni products. 139.115 Enriched macaroni products. 139.117 Enriched macaroni products with fortified protein. 139.120 Milk macaroni products. 139.121 Nonfat milk macaroni products. 139.122 Enriched nonfat milk macaroni products. 139.125 Vegetable macaroni products. 139.135 Enriched vegetable macaroni prod ucts. 139.138 Whole wheat macaroni products. 139.140 Wheat and soy macaroni products. 139.150 Noodle products. 139.155 Enriched noodle products. 139.160 Vegetable noodle products. 139.165 Enriched vegetable noodle products. 139.180 Wheat and soy noodle products. AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. SOURCE: 42 FR 14409, Mar. 15, 1977, unless otherwise noted. Subpart A [Reserved] Subpart B—Requirements for Spe cific Standardized Macaroni and Noodle Products § 139.110 Macaroni products. (a) Macaroni products are the class of food each of which is prepared by dry ing formed units of dough made from semolina, durum flour, farina, flour, or any combination of two or more of these, with water and with or without one or more of the optional ingredients specified in paragraphs (a) (1) to (6), in clusive, of this section. (1) Egg white, frozen egg white, dried egg white, or any two or all of these, in such quantity that the solids thereof are not less than 0.5 percent and not more than 2.0 percent of the weight of the finished food. (2) Disodium phosphate, in a quantity not less than 0.5 percent and not more than 1.0 percent of the weight of the finished food. (3) Onions, celery, garlic, bay leaf, or any two or more of these, in a quantity which seasons the food. (4) Salt, in a quantity which seasons the food. (5) Gum gluten, in such quantity that the protein content of the finished food is not more than 13 percent by weight. The finished macaroni product con tains not less than 87 percent of total solids as determined by the method prescribed in ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), in section 14.133, under the heading ‘‘Vacuum Oven Method—Official Final Action,’’ which is incorporated by ref erence. 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 Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (6) Concentrated glyceryl monostea rate (containing not less than 90 per cent monoester), in a quantity not ex ceeding 2 percent by weight of the fin ished food. (b) Macaroni is the macaroni product the units of which are tube-shaped and more than 0.11 inch but not more than 0.27 inch in diameter. (c) Spaghetti is the macaroni product the units of which are tube-shaped or cord-shaped (not tubular) and more than 0.06 inch but not more than 0.11 inch in diameter. (d) Vermicelli is the macaroni prod uct the units of which are cord-shaped (not tubular) and not more than 0.06 inch in diameter. (e) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘Macaroni product’’; or alternatively, the name is ‘‘Macaroni’’, ‘‘Spaghetti’’, or ‘‘Vermicelli’’, as the case may be, when the units of the food are of the shapes VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00553 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 544 21 CFR Ch. I (4–1–16 Edition) § 139.115 and sizes specified in paragraph (b), (c), or (d), respectively, of this section. (f)(1) When disodium phosphate is used the label shall bear the statement ‘‘Disodium phosphate added for quick cooking’’. (2) When any ingredient specified in paragraph (a)(3) of this section is used the label shall bear the statement ‘‘Seasoned with lll’’, the blank being filled in with the common name of the ingredient; or in the case of bay leaves the statement ‘‘Spiced’’, ‘‘Spice added’’, or ‘‘Spiced with bay leaves’’. (3) When the ingredient specified in paragraph (a)(6) of this section is used, the label shall bear the statement ‘‘Glyceryl monostearate added’’ or the statement ‘‘With added glyceryl mono stearate’’. (4) Wherever the name of the food ap pears on the label so conspicuously as to be easily seen under customary con ditions of purchase, the words and statements prescribed in this section, showing the optional ingredients used, shall immediately and conspicuously precede or follow, or in part precede and in part follow, such name, without intervening written, printed, or graph ic matter. (g) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14409, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19, 1982; 49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] § 139.115 Enriched macaroni products. (a) Description. Enriched macaroni products are the class of food each of which conforms to the definition and standard of identity and is subject to the requirements for label statement of ingredients, prescribed for macaroni products by § 139.110(a), (f), and (g), ex cept that: (1) Each such food contains in each pound not less than 4.0 milligrams (mg) and not more than 5.0 mg of thiamin, not less than 1.7 mg and not more than 2.2 mg of riboflavin, not less than 27 mg and not more than 34 mg of niacin or niacinamide, not less than 0.9 mg and not more than 1.2 mg of folic acid, and not less than 13 mg and not more than 16.5 mg of iron (Fe); (2) Each such food may also contain as an optional ingredient added vita min D in such quantity that each pound of the finished food contains not less than 250 U.S.P. units and not more than 1000 U.S.P. units of vitamin D. (3) Each such food may also contain as an optional ingredient added cal cium in such quantity that each pound of the finished food contains not less than 500 mg. and not more than 625 mg. of calcium (Ca); (4) Each such food may also contain as an optional ingredient partly defatted wheat germ but the amount thereof does not exceed 5 percent of the weight of the finished food; (5) Each such food may be supplied, wholly or in part, with the prescribed quantity of any substance referred to in paragraphs (a) (1), (2), and (3) of this section through the use of dried yeast, dried torula yeast, partly defatted wheat germ, enriched farina, or en riched flour, or through the direct ad ditions of any of the substances pre scribed in paragraphs (a) (1), (2), and (3) of this section. Iron and calcium may be added only in forms which are harmless and assimi lable. The substances referred to in paragraphs (a) (1) and (2) of this section may be added in a harmless carrier which does not impair the enriched macaroni product, such carrier being used only in the quantity reasonably necessary to effect an intimate and uniform distribution of such sub stances in the finished enriched maca roni product. (b) Enriched macaroni is the enriched macaroni product the units of which conform to the specifications of shape and size prescribed for macaroni by § 139.110(b). (c) Enriched spaghetti is the enriched macaroni product the units of which conform to the specifications of shape and size prescribed for spaghetti by § 139.110(c). (d) Enriched vermicelli is the en riched macaroni product the units of which conform to the specifications of shape and size prescribed for vermicelli by § 139.110(d). (e) The name of each food for which a definition and standard of identity is VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00554 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 545 Food and Drug Administration, HHS § 139.117 prescribed by this section is ‘‘Enriched Macaroni product’’; or alternatively, the name is ‘‘Enriched macaroni’’, ‘‘Enriched spaghetti’’, or ‘‘Enriched vermicelli’’, as the case may be, when the units of the food comply with the requirements of paragraphs (b), (c), or (d) respectively of this section. [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993; 61 FR 8797, Mar. 5, 1996] § 139.117 Enriched macaroni products with fortified protein. (a)(1) Each of the foods for which a standard of identity is prescribed by this section is produced by drying formed units of dough made with one or more of the milled wheat ingredi ents designated in §§ 139.110(a) and 139.138(a), and other ingredients to en able the finished food to meet the pro tein requirements set out in paragraph (a)(2)(i) of this section. Edible protein sources, including food grade flours or meals made from nonwheat cereals or from oilseeds, may be used. Vitamin and mineral enrichment nutrients are added to bring the food into conformity with the requirements of paragraph (b) of this section. Safe and suitable ingre dients, as provided for in paragraph (c) of this section, may be added. The pro portion of the milled wheat ingredient is larger than the proportion of any other ingredient used. (2) Each such finished food, when tested by the methods described in the cited sections of ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), 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 Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.), meets the fol lowing specifications: (i) The protein content (N × 6.25) is not less than 20 percent by weight (on a 13 percent moisture basis) as deter mined by the method in section 14.142. The protein quality is not less than 95 percent that of casein as determined on the cooked food by the method in sec tions 43.212 through 43.216 of the offi cial methods. (ii) The total solids content is not less than 87 percent by weight as deter mined by the method in section 14.133 of the official methods. (b)(1) Each food covered by this sec tion contains in each pound 5 milli grams of thiamin, 2.2 milligrams of ri boflavin, 34 milligrams of niacin or nia cinamide, and 16.5 milligrams of iron. (2) Each pound of such food may also contain 625 milligrams of calcium. (3) Iron and calcium may be added only in forms which are harmless and assimilable. The enrichment nutrients may be added in a harmless carrier used only in a quantity necessary to ef fect a uniform distribution of the nu trients in the finished food. The re quirements of paragraphs (b) (1) and (2) of this section shall be deemed to have been met if reasonable overages, within the limits of good manufacturing prac tice, are present to assure that the pre scribed levels of the vitamins and min eral(s) are maintained throughout the expected shelf life of the food under customary conditions of distribution. (c) The safe and suitable ingredients referred to in paragraph (a) of this sec tion are ingredients that serve a useful purpose, e.g., to fortify the protein or facilitate production of the food, but they do not include color additives, ar tificial flavorings, artificial sweet eners, chemical preservatives, or starches. Ingredients deemed suitable for use by this paragraph are added in amounts that are not in excess of those reasonably required to achieve their in tended purposes. Ingredients are deemed to be safe if they are not food additives within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act, or in case they are food additives, if they are used in con formity with regulations established pursuant to section 409 of the act. (d)(1) The name of any food covered by this section is ‘‘Enriched Wheat lll Macaroni Product—with For tified Protein’’, the blank being filled in with appropriate word(s) such as ‘‘Soy’’ to show the source of any flours or meals used that were made from nonwheat cereals or from oilseeds. In lieu of the words ‘‘Macaroni Product’’ VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00555 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 546 21 CFR Ch. I (4–1–16 Edition) § 139.120 the word ‘‘Macaroni’’, ‘‘Spaghetti’’, or ‘‘Vermicelli’’, as appropriate, may be used if the units conform in shape and size to the requirements of § 139.110 (b), (c), or (d). (2) When any ingredient, not des ignated in the part of the name pre scribed in paragraph (d)(1) of this sec tion, is added in such proportion as to contribute 10 percent or more of the quantity of protein contained in the finished food, the name shall include the statement ‘‘Made with lll’’, the blank being filled in with the name of each such ingredient, e.g., ‘‘Made with nonfat milk’’. (3) When, in conformity with para graph (d) (1) or (2) of this section, two or more ingredients are listed in the name, their designations shall be ar ranged in descending order of predomi nance by weight. (4) In the case of a food made to com ply with another section of this part, but which also meets the compositional requirements of this sec tion, it may alternatively bear the name set out in that other section. (e) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14409, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19, 1982; 49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] EFFECTIVE DATE NOTE: Section 139.117 was stayed in its entirety at 43 FR 11695, Mar. 21, 1978. § 139.120 Milk macaroni products. (a) Milk macaroni products are the class of food, each of which conforms to the definition and standard of identity and is subject to the requirements for label statement of ingredients pre scribed for macaroni products by § 139.110(a), (f)(2), (f)(3), and (g), except that: (1) Milk is used as the sole moist ening ingredient in preparing the dough; or in lieu of milk one or more of the milk ingredients specified in para graph (f) of this section is used, with or without water, in such quantity that the weight of milk solids therein is not less than 3.8 percent of the weight of the finished milk macaroni product; and (2) None of the optional ingredients permitted by § 139.110(a) (1) and (2) is used. When the optional ingredient gum gluten (§ 139.110(a)(5)) is added, the quantity is such that the protein de rived therefrom, together with the pro tein derived from semolina, durum flour, farina, flour, or any combination of these used, does not exceed 13 per cent of the weight of the finished food. (b) Milk macaroni is the milk maca roni product the units of which con form to the specifications of shape and size prescribed for macaroni by § 139.110(b). (c) Milk spaghetti is the milk maca roni product the units of which con form to the specifications of shape and size prescribed for spaghetti by § 139.110(c). (d) Milk vermicelli is the milk maca roni product the units of which con form to the specifications of shape and size prescribed for vermicelli by § 139.110(d). (e) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘Milk Macaroni Product’’; or alternatively, the name is ‘‘Milk macaroni’’, ‘‘Milk spaghetti’’, or ‘‘Milk vermicelli’’, as the case may be, when the units of the food comply with the requirements of paragraph (b), (c), or (d), respectively, of this section. (f) The milk ingredients referred to in paragraph (a)(1) of this section are concentrated milk, evaporated milk, dried milk, and a mixture of butter with skim milk, concentrated skim milk, evaporated skim milk, nonfat dry milk (dried skim milk), or any two or more of these, in such proportion that the weight of nonfat milk solids in such mixture is not more than 2.275 times the weight of milk fat therein. [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993] § 139.121 Nonfat milk macaroni prod ucts. (a) Each of the macaroni products made with nonfat milk for which a def inition and standard of identity is pre scribed by this section conforms to the definition and standard of identity, and is subject to the requirements for label VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00556 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 547 Food and Drug Administration, HHS § 139.122 statement of ingredients, prescribed for macaroni products by § 139.110(a), (f)(2), (f)(3), (f)(4), and (g), except that: (1)(i) In preparing the dough, nonfat dry milk or concentrated skim milk, or a mixture of these, is used in an amount such that the finished maca roni product made with nonfat milk contains by weight not less than 12 per cent and not more than 25 percent of milk solids-not-fat. Carrageenan or salts of carrageenan conforming to the requirements of §§ 172.620 and 172.626 of this chapter may be used in a quantity not in excess of 0.833 percent by weight of the milk solids-not-fat used. (ii) When the ingredient carrageenan or the salts of carrageenan specified in paragraph (a)(1)(i) of this section is used, the label shall bear the state ment, ‘‘Carrageenan added’’ or ‘‘Salts of carrageenan added’’ or the state ment ‘‘With added carrageenan’’ or ‘‘With added salts of carrageenan’’, in the manner further prescribed by § 139.110(f)(4). (2) None of the optional ingredients permitted by § 139.110(a) (1), (2), and (5) are used. (b) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘Macaroni products made with nonfat milk’’ or, alternatively, the name is ‘‘Macaroni made with nonfat milk’’, ‘‘Spaghetti made with nonfat milk’’ or ‘‘Vermicelli made with nonfat milk’’, as the case may be when the units of the food con form to the specifications of shape and size prescribed by § 139.110 (b), (c), or (d), respectively. [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993] § 139.122 Enriched nonfat milk maca roni products. (a) Each of the enriched macaroni products made with nonfat milk for which a definition and standard of identity is prescribed by this section conforms to the definition and stand ard of identity, and is subject to the re quirements for label statement of in gredients, prescribed for macaroni products by § 139.110(a), (f)(2), (f)(3), (f)(4), and (g), except that: (1)(i) In preparing the dough, nonfat dry milk or concentrated skim milk, or a mixture of these, is used in an amount such that the finished enriched macaroni product made with nonfat milk contains by weight not less than 12 percent and not more than 25 per cent of milk solids-not-fat. Carra geenan or the salts of carrageenan con forming to the requirements of § 172.620 and § 172.626 of this chapter may be used in a quantity not in excess of 0.833 percent by weight of the milk solids not-fat used. (ii) When the ingredient carrageenan or the salts of carrageenan specified in paragraph (a)(1)(i) of this section is used, the label shall bear the state ment, ‘‘Carrageenan added’’ or ‘‘Salts of carrageenan added’’ or the state ment ‘‘With added carrageenan’’ or ‘‘With added salts of carrageenan’’, in the manner further prescribed by § 139.110(f)(4). (2) None of the optional ingredients permitted by § 139.110(a) (1), (2), and (5) are used. (3) Each such food contains in each pound not less than 4.0 milligrams (mg) and not more than 5.0 mg of thiamin, not less than 1.7 mg and not more than 2.2 mg of riboflavin, not less than 27 mg and not more than 34 mg of niacin or niacinamide, not less than 0.9 mg and not more than 1.2 mg of folic acid, and not less than 13 mg and not more than 16.5 mg of iron (Fe). These substances may be added through direct addition or wholly or in part through the use of dried yeast, dried torula yeast, partly defatted wheat germ (as provided for in paragraph (a)(4) of this section), en riched farina, or enriched flour. They may be added in a harmless carrier, such carrier being used only in the quantity reasonably necessary to effect an intimate and uniform distribution of such substances in the finished food. Iron may be added only in a form that is harmless and assimilable. (4) Each such food may also contain as an optional ingredient partly defatted wheat germ, but the amount thereof does not exceed 5 percent by weight of the finished food. (b) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘Enriched macaroni product made with nonfat milk’’ or, alternatively, the name is ‘‘Enriched macaroni made with nonfat milk’’, ‘‘Enriched spaghetti made with VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00557 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 548 21 CFR Ch. I (4–1–16 Edition) § 139.125 nonfat milk’’, or ‘‘Enriched vermicelli made with nonfat milk,’’ as the case may be when the units of the food con form to the specifications of shape and size prescribed by § 139.110 (b), (c), or (d), respectively. [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993] § 139.125 Vegetable macaroni prod ucts. (a) Vegetable macaroni products are the class of food each of which con forms to the definition and standard of identity and is subject to the require ments for label statement of ingredi ents prescribed for macaroni products by § 139.110(a), (f)(2), (f)(3), and (g), ex cept that: (1) Tomato (of any red variety), arti choke, beet, carrot, parsley, or spinach is added in such quantity that the sol ids thereof are not less than 3 percent by weight of the finished vegetable macaroni product (the vegetable used may be fresh, canned, dried, or in the form of puree or paste); and (2) None of the optional ingredients permitted by § 139.110(a) (1) and (2) is used. When the optional ingredient gum gluten (§ 139.110(a)(5)) is added, the quantity is such that the protein de rived therefrom, together with the pro tein derived from the semolina, durum flour, farina, flour or any combination of these used, does not exceed 13 per cent of the weight of the finished food. (b) Vegetable macaroni is the vege table macaroni product the units of which conform to the specifications of shape and size prescribed for macaroni by § 139.110(b). (c) Vegetable spaghetti is the vege table macaroni product the units of which conform to the specifications of shape and size prescribed for spaghetti by § 139.110(c). (d) Vegetable vermicelli is the vege table macaroni product, the units of which conform to the specifications of shape and size prescribed for vermicelli by § 139.110(d). (e) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘lll macaroni product’’, the blank being filled in with the name whereby the vegetable used is designated in para graph (a) of this section; or alter natively, the name is ‘‘lll maca roni’’, ‘‘lll spaghetti’’, or ‘‘lll vermicelli’’, as the case may be, when the units of the food comply with the requirements of paragraph (b), (c), or (d) of this section, respectively, the blank in each instance being filled in with the name whereby the vegetable used is designated in paragraph (a) of this section. [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993] § 139.135 Enriched vegetable macaroni products. (a) Each of the macaroni products for which a definition and standard of identity is prescribed by this section conforms to the definition and stand ard of identity and is subject to the re quirements for label statement of in gredients prescribed for macaroni prod ucts by § 139.110(a), (f), and (g), and in addition is enriched to meet the re quirements prescribed for enriched macaroni products by § 139.115 and con tains a vegetable ingredient in compli ance with the requirements prescribed for vegetable macaroni products by § 139.125. (b) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘Enriched lll macaroni product’’, or, alter natively, the name is ‘‘Enriched lll macaroni’’, ‘‘Enriched lll spa ghetti’’, or ‘‘Enriched lll vermicelli’’, when the units comply with the shape and size requirements prescribed for macaroni, spaghetti, or vermicelli in § 139.110 (b), (c), or (d). The blank in each instance is filled in with the name of the vegetable used, as specified in § 139.125(a). For example, the name of an enriched macaroni product containing the prescribed amount of spinach and made in units not conforming in shape and size to the requirements for macaroni, spaghetti, or vermicelli is ‘‘Enriched spinach macaroni product’’. [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993] § 139.138 Whole wheat macaroni prod ucts. (a) Whole wheat macaroni products are the class of food each of which con forms to the definition and standard of VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00558 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 549 Food and Drug Administration, HHS § 139.140 identity and is subject to the require ments for label statement of ingredi ents, prescribed for macaroni products by § 139.110(a), (f)(2), (f)(3), and (g), ex cept that: (1) Whole wheat flour or whole durum wheat flour or both are used as the sole wheat ingredient; and (2) None of the optional ingredients permitted by § 139.110(a) (1), (2), and (5) is used. (b) Whole wheat macaroni is the whole wheat macaroni product the units of which conform to the speci fications of shape and size prescribed for macaroni by § 139.110(b). (c) Whole wheat spaghetti is the whole wheat macaroni product the units of which conform to the speci fications of shape and size prescribed for spaghetti by § 139.110(c). (d) Whole wheat vermicelli is the whole wheat macaroni product the units of which conform to the speci fications of shape and size prescribed for vermicelli by § 139.110(d). (e) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘Whole wheat macaroni product’’; or alter natively, the name is ‘‘Whole wheat macaroni’’, ‘‘Whole wheat spaghetti’’, or ‘‘Whole wheat vermicelli’’, as the case may be, when the units of the food comply with the requirements of para graph (b), (c), or (d), respectively, of this section. [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993] § 139.140 Wheat and soy macaroni products. (a) Wheat and soy macaroni products are the class of food each of which con forms to the definition and standard of identity and is subject to the require ments for label statement of ingredi ents, prescribed for macaroni products by § 139.110(a), (f)(2), (f)(3), and (g), ex cept that: (1) Soy flour is added in a quantity not less than 12.5 percent of the com bined weight of the wheat and soy in gredients used (the soy flour used is made from heat-processed, dehulled soybeans, with or without the removal of fat therefrom); and (2) None of the optional ingredients permitted by § 139.110(a) (1) and (2) is used. When the optional ingredient gum gluten (§ 139.110(a)(5)) is added, the quantity is such that the protein de rived therefrom, together with the pro tein derived from semolina, durum flour, farina, flour or any combination of these used, does not exceed 13 per cent of the weight of the finished food. (b) Wheat and soy macaroni is the wheat and soy macaroni product the units of which conform to the speci fications of shape and size prescribed for macaroni by § 139.110(b). (c) Wheat and soy spaghetti is the wheat and soy macaroni product the units of which conform to the speci fications of shape and size prescribed for spaghetti by § 139.110(c). (d) Wheat and soy vermicelli is the wheat and soy macaroni product the units of which conform to the speci fications of shape and size prescribed for vermicelli by § 139.110(d). (e) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘Wheat and soy macaroni product’’, ‘‘Wheat and soybean macaroni product’’, ‘‘lll and soy macaroni product’’, or ‘‘lll and soybean macaroni prod uct’’, the blank in each instance being filled in with the name whereby the wheat ingredient used is designated in § 139.110(a); or alternatively, the name is ‘‘Wheat and soy macaroni’’, ‘‘Wheat and soybean macaroni’’, ‘‘lll and soy macaroni’’, or ‘‘lll and soybean macaroni’’ when the units of the food comply with the requirements of para graph (b) of this section; or ‘‘Wheat and soy spaghetti’’, ‘‘Wheat and soybean spaghetti’’, ‘‘lll and soy spaghetti’’, or ‘‘lll and soybean spaghetti’’ when such units comply with the require ments of paragraph (c) of this section; or ‘‘Wheat and soy vermicelli’’, ‘‘Wheat and soybean vermicelli’’, ‘‘lll and soy vermicelli’’, or ‘‘lll and soybean vermicelli’’ when such units comply with the requirements of paragraph (d) of this section, the blank in each in stance being filled in with the name whereby the wheat ingredient used is designated in § 139.110(a). [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993] VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00559 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 550 21 CFR Ch. I (4–1–16 Edition) § 139.150 § 139.150 Noodle products. (a) Noodle products are the class of food each of which is prepared by dry ing formed units of dough made from semolina, durum flour, farina, flour, or any combination of two or more of these, with liquid eggs, frozen eggs, dried eggs, egg yolks, frozen yolks, dried yolks, or any combination of two or more of these, with or without water and with or without one or more of the optional ingredients specified in para graphs (a) (1) to (4) of this section in clusive: (1) Onions, celery, garlic, bay leaf, or any two or more of these, in a quantity which seasons the food. (2) Salt, in a quantity which seasons the food. (3) Gum gluten, in such quantity that the protein derived therefrom, together with the protein derived from semo lina, durum flour, farina, flour or any combination of these used, does not ex ceed 13 percent of the weight of the fin ished food. (4) Concentrated glyceryl monostea rate (containing not less than 90 per cent monoester) in a quantity not ex ceeding 3 percent by weight of the fin ished food. The finished noodle product contains not less than 87 percent of total solids as determined by the method pre scribed in ‘‘Official Methods of Anal ysis of the Association of Official Ana lytical Chemists,’’ 13th Ed. (1980), in section 14.133, under the heading ‘‘Vac uum Oven Method—Official Final Ac tion,’’ which is incorporated by ref erence. 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 Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. The total solids of noodle products contains not less than 5.5 percent by weight of the solids of egg, or egg yolk. (b) Noodles, egg noodles, is the noo dle product the units of which are rib bon-shaped. (c) Egg macaroni is the noodle prod uct the units of which are tube-shaped and more than 0.11 inch but not more than 0.27 inch in diameter. (d) Egg spaghetti is the noodle prod uct the units of which are tube-shaped or cord-shaped (not tubular) and more than 0.06 inch but not more than 0.11 inch in diameter. (e) Egg vermicelli is the noodle prod uct the units of which are cord-shaped (not tubular) and not more than 0.06 inch in diameter. (f) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘Noodle product’’ or ‘‘Egg noodle product’’; or alternatively, the name is ‘‘Noodles’’ or ‘‘Egg noodles’’, ‘‘Egg macaroni’’, ‘‘Egg spaghetti’’, or ‘‘Egg vermicelli’’, as the case may be, when the units of the food are of the shapes and sizes specified in paragraph (b), (c), (d), or (e), respectively, of this section. (g)(1) When any ingredient specified in paragraph (a)(1) of this section is used, the label of the noodle product shall bear the statement ‘‘Seasoned with lll’’, the blank being filled in with the common name of the ingre dient; or in the case of bay leaves, the statement ‘‘Spiced’’, ‘‘Spice added’’, or ‘‘Spiced with bay leaves’’. (2) When the ingredient specified in paragraph (a)(4) of this section is used, the label shall bear the statement ‘‘Glyceryl monostearate added’’ or the statement ‘‘With added glyceryl mono stearate’’. (h) Wherever the name of the food ap pears on such label so conspicuously as to be easily seen under customary con ditions of purchase, the words and statements prescribed in this section, showing the ingredients used shall im mediately and conspicuously precede or follow, or in part precede and in part follow, such name without intervening written, printed, or other graphic mat ter. (i) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14409, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19, 1982; 49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2879, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00560 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 551 Food and Drug Administration, HHS § 139.160 § 139.155 Enriched noodle products. (a) Enriched noodle products are the class of food each of which conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, pre scribed for noodle products by § 139.150 (a), (g), and (i), except that: (1) Each such food contains in each pound not less than 4 milligrams (mg) and not more than 5 mg of thiamin, not less than 1.7 mg and not more than 2.2 mg of riboflavin, not less than 27 mg and not more than 34 mg of niacin or niacinamide, not less than 0.9 mg and not more than 1.2 mg of folic acid, and not less than 13 mg and not more than 16.5 mg of iron (Fe); (2) Each such food may also contain as an optional ingredient added vita min D in such quantity that each pound of the finished food contains not less than 250 U.S.P. units and not more than 1000 U.S.P. units of vitamin D; (3) Each such food may also contain as an optional ingredient added cal cium in such quantity that each pound of the finished food contains not less than 500 mg. and not more than 625 mg. of calcium (Ca); (4) Each such food may also contain as an optional ingredient partly defatted wheat germ, but the amount thereof does not exceed 5 percent of the weight of the finished food; (5) Each such food may be supplied, wholly or in part, with the prescribed quantity of any substance referred to in paragraphs (a) (1), (2), and (3) of this section through the use of dried yeast, dried torula yeast, partly defatted wheat germ, enriched farina, or en riched flour, or through the direct ad ditions of any of the substances pre scribed in paragraphs (a) (1), (2), and (3) of this section. Iron and calcium may be added only in forms which are harmless and assimi lable. The substances referred to in paragraphs (a) (1) and (2) of this section may be added in a harmless carrier which does not impair the enriched noodle product, such carrier being used only in the quantity reasonably nec essary to effect an intimate and uni form distribution of such substances in the finished enriched noodle product. (b) Enriched noodles, enriched egg noodles are the enriched noodle prod ucts the units of which conform to the specifications of shape and size pre scribed for noodles in § 139.150(b). (c) Enriched egg macaroni is the en riched noodle product the units of which conform to the specifications of shape and size prescribed for egg maca roni in § 139.150(c). (d) Enriched egg spaghetti is the en riched noodle product the units of which conform to the specifications of shape and size prescribed for egg spa ghetti in § 139.150(d). (e) Enriched egg vermicelli is the en riched noodle product the units of which conform to the specifications of shape and size prescribed for egg vermicelli in § 139.150(e). (f) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘Enriched noodle product’’ or ‘‘Enriched egg noo dle product’’; or alternatively, the name is ‘‘Enriched noodles’’, or ‘‘En riched egg noodles’’, ‘‘Enriched egg macaroni’’, ‘‘Enriched egg spaghetti’’, or ‘‘Enriched egg vermicelli’’, as the case may be, when the units of the food comply with the requirements of para graph (b), (c), (d), or (e) respectively of this section. [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993] § 139.160 Vegetable noodle products. (a) Vegetable noodle products are the class of food each of which conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, pre scribed for noodle products by § 139.150(a), (g), and (i), except that to mato (of any red variety), artichoke, beet, carrot, parsley, or spinach is added in such quantity that the solids thereof are not less than 3 percent by weight of the finished vegetable noodle product (the vegetable used may be fresh, canned, dried, or in the form of puree or paste). (b) Vegetable noodles, vegetable egg noodles, is the vegetable noodle prod uct the units of which are ribbon shaped. (c) Vegetable egg macaroni is the vegetable noodle product the units of which conform to the specifications of VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00561 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 552 21 CFR Ch. I (4–1–16 Edition) § 139.165 shape and size prescribed for egg maca roni by § 139.150(c). (d) Vegetable egg spaghetti is the vegetable noodle product the units of which conform to the specifications of shape and size prescribed for egg spa ghetti by § 139.150(d). (e) Vegetable egg vermicelli is the vegetable noodle product the units of which conform to the specifications of shape and size prescribed for egg vermicelli by § 139.150(e). (f) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘lll noodle product’’ or ‘‘lll egg noodle product’’, the blank being filled in with the name whereby the vegetable used is designated in paragraph (a) of this sec tion; or alternatively, the name is ‘‘lll noodles’’ or ‘‘lll egg noo dles’’, ‘‘lll egg macaroni’’, ‘‘lll egg spaghetti’’, or ‘‘lll egg vermicelli’’, as the case may be, when the units of the food comply with the requirements of paragraph (b), (c), (d), or (e) of this section, respectively, the blank in each instance being filled in with the name whereby the vegetable is designated in paragraph (a) of this section. [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993] § 139.165 Enriched vegetable noodle products. (a) Each of the noodle products for which a definition and standard of identity is prescribed by this section conforms to the definition and stand ard of identity and is subject to the re quirements for label declaration of in gredients prescribed for noodle prod ucts by § 139.150 (a), (g), (h), and (i), and in addition is enriched to meet the re quirements prescribed for enriched noodle products by § 139.155 and, except as hereinafter provided, contains a veg etable ingredient in compliance with the requirements prescribed for vege table noodle products by § 139.160. Be cause they are apt to impart an egg yolk color, carrots are not used in en riched vegetable noodle products. (b) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘Enriched lll noodle product’’, ‘‘Enriched lll egg noodle product’’, or, alter natively, the name is ‘‘Enriched lll noodles’’, or ‘‘Enriched lll egg noo dles’’, ‘‘Enriched lll egg macaroni’’, ‘‘Enriched lll egg spaghetti’’, or ‘‘Enriched lll egg vermicelli’’, when the units comply with the size and shape requirements for noodles, maca roni, spaghetti, or vermicelli in § 139.150 (b), (c), (d), or (e). The blank in each in stance is filled in with the name of the vegetable used, as specified in § 139.160(a). [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993] § 139.180 Wheat and soy noodle prod ucts. (a) Wheat and soy noodle products are the class of food each of which con forms to the definition and standard of identity and is subject to the require ments for label statement of ingredi ents prescribed for noodle products by § 139.150(a), (g), and (i), except that soy flour is added in a quantity not less than 12.5 percent of the combined weight of the wheat and soy ingredi ents used (the soy flour used is made from heat-processed, dehulled soy beans, with or without the removal of fat therefrom). (b) Wheat and soy noodles, wheat and soy egg noodles, is the wheat and soy noodle product the units of which are ribbon-shaped. (c) Wheat and soy egg macaroni is the wheat and soy noodle product the units of which conform to the speci fications of shape and size prescribed for egg macaroni by § 139.150(c). (d) Wheat and soy egg spaghetti is the wheat and soy noodle product the units of which conform to the speci fications of shape and size prescribed for egg spaghetti by § 139.150(d). (e) Wheat and soy egg vermicelli is the wheat and soy noodle product the units of which conform to the speci fications of shape and size prescribed for egg vermicelli by § 139.150(e). (f) The name of each food for which a definition and standard of identity is prescribed by this section is ‘‘Wheat and soy noodle product’’, ‘‘Wheat and soy egg noodle product’’, ‘‘Wheat and soybean noodle product’’, ‘‘Wheat and soybean egg noodle product’’, ‘‘lll and soy noodle product’’, ‘‘lll and soy egg noodle product’’, ‘‘lll and VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00562 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 553 Food and Drug Administration, HHS § 145.3 soybean noodle product’’, or ‘‘lll and soybean egg noodle product’’, the blank in each instance being filled in with the name whereby the wheat in gredient used is designated in § 139.150(a); or alternatively, the name is ‘‘Wheat and soy noodles’’, ‘‘Wheat and soy egg noodles’’, ‘‘Wheat and soy bean noodles’’, ‘‘Wheat and soybean egg noodles’’, ‘‘lll and soy noodles’’, ‘‘lll and soy egg noodles’’, ‘‘lll and soybean noodles’’, or ‘‘lll and soybean egg noodles’’ when the units of the food comply with the requirements of paragraph (b) of this section; or ‘‘Wheat and soy egg macaroni’’, ‘‘Wheat and soybean egg macaroni’’, ‘‘lll and soy egg macaroni’’, or ‘‘lll and soybean egg macaroni’’ when such units comply with the re quirements of paragraph (c) of this sec tion; or ‘‘Wheat and soy egg spa ghetti’’, ‘‘Wheat and soybean egg spa ghetti’’, ‘‘lll and soy egg spaghetti’’, or ‘‘lll and soybean egg spaghetti’’ when such units comply with the re quirements of paragraph (d) of this sec tion; or ‘‘Wheat and soy egg vermicelli’’, ‘‘Wheat and soybean egg vermicelli’’, ‘‘lll and soy egg vermicelli’’, or ‘‘lll and soybean egg vermicelli’’, when such units comply with the requirements of paragraph (e) of this section, the blank in each in stance being filled in with the name whereby the wheat ingredient used is designated in § 139.150(a). [42 FR 14409, Mar. 15, 1977, as amended at 58 FR 2879, Jan. 6, 1993] PART 145—CANNED FRUITS Subpart A—General Provisions Sec. 145.3 Definitions. Subpart B—Requirements for Specific Standardized Canned Fruits 145.110 Canned applesauce. 145.115 Canned apricots. 145.116 Artificially sweetened canned apri cots. 145.120 Canned berries. 145.125 Canned cherries. 145.126 Artificially sweetened canned cher ries. 145.130 Canned figs. 145.131 Artificially sweetened canned figs. 145.134 Canned preserved figs. 145.135 Canned fruit cocktail. 145.136 Artificially sweetened canned fruit cocktail. 145.140 Canned seedless grapes. 145.145 Canned grapefruit. 145.170 Canned peaches. 145.171 Artificially sweetened canned peach es. 145.175 Canned pears. 145.176 Artificially sweetened canned pears. 145.180 Canned pineapple. 145.181 Artificially sweetened canned pine apple. 145.185 Canned plums. 145.190 Canned prunes. AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. SOURCE: 42 FR 14414, Mar. 15, 1977, unless otherwise noted. Subpart A—General Provisions § 145.3 Definitions. For the purposes of this part: (a) The term corn sirup means a clari fied, concentrated aqueous solution of the products obtained by the incom plete hydrolysis of cornstarch, and in cludes dried corn sirup. The solids of corn sirup and of dried corn sirup con tain not less than 40 percent by weight of reducing sugars calculated as anhy drous dextrose. (b) The term dextrose means the hy drated or anhydrous, refined monosaccharide obtained from hydrolyzed starch. (c) The term dried glucose sirup means the product obtained by drying ‘‘glu cose sirup.’’ (d) The term glucose sirup means a clarified, concentrated, aqueous solu tion of the products obtained by the in complete hydrolysis of any edible starch. The solids of glucose sirup con tain not less than 40 percent by weight of reducing sugars calculated as anhy drous dextrose. (e) The term invert sugar sirup means an aqueous solution of inverted or partly inverted, refined or partly re fined sucrose, the solids of which con tain not more than 0.3 percent by weight of ash, and which is colorless, odorless, and flavorless, except for sweetness. (f) The term sugar means refined su crose. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00563 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B