of the regulations in Part 121 of this chapter shall apply with respect to the information that must be submitted with respect to the food additive. Since section 409 (b) (5) of the act requires that the Commissioner publish notice of a petition for the establishment of a foodadditive regulation within 30 days after filing, notice of a petition relating to a definition and standard of identity shall also be published within that time limitation if it includes a request, so designated, for the establishment of a regulation pertaining to a food additive. (b) If a petition for a definition and standard of identity contains a proposal for a food-additive regulation, and the petitioner fails to designate it as such, the Commissioner, upon determining that the petition includes a proposal for a food-additive regulation, shall so notify the petitioner and shall thereafter proceed in accordance with the regulations in Part 121 of this chapter. § 10.5 Temporary permits for interstate shipment of experimental packs of food varying from the requirements of definitions and standards of identity. (a) The Food and Drug Administration recognizes that appropriate investigations of potential advances in food technology sometimes require tests in interstate markets of the advantages to and acceptance by consumers of variations in foods from applicable definitions and standards of identity prescribed under section 401 of the act. (b) It is the purpose of the Administration to permit such tests where they are necessary to the completion or conclusiveness of an otherwise adequate investigation and where the interests of consumers are adequately safeguarded. The Administration will therefore refrain from recommending regulatory proceedings under the act on the charge that a food does not conform to an applicable standard, if the person who introduces or causes the introduction of the food into interstate commerce holds an effective permit from the Commissioner providing specifically for those variations in respect to which the food fails to conform to the applicable definition and standard of identity. (c) Any person desiring a permit may file with the Commissioner a written application in triplicate containing as part thereof the following: (1) Name and address of the applicant. (2) A statement of whether or not the applicant is regularly engaged in producing the food involved. (3) A reference to the applicable defnition and standard of identity (citing applicable section of regulations). (4) A full description of the proposed variation from the standard. (5) The basis upon which the food so varying is believed to be wholesome and nondeleterious. (6) The amount of any new ingredient to be added; the amount of any ingredient, required by the standard, to be eliminated; any change of concentration not contemplated by the standard; or any change in name that would more appropriately describe the new product under test. If such new ingredient is not a commonly known food ingredient, a description of its properties and basis for concluding that it is not a deleterious substance. (7) The purpose of effecting the variation. (8) A statement of how the variation is of potential advantage to consumers. (9) The labeling proposed to be used for the food so varying. (10) The period during which the applicant desires to introduce such food into interstate commerce, with a statement of the reasons supporting the need for such period. (11) The probable amount of such food that will be distributed. (12) The areas of distribution. (13) The address at which such food will be manufactured. (14) A statement of whether or not such food has been or is to be distributed in the State in which it was manufactured. (15) If it has not been or is not to be so distributed, a statement showing why. (16) If it has been or is to be so distributed, a statement of why it is deemed necessary to distribute such food in other States. (d) The Commissioner may require the applicant to furnish samples of the food varying from the standard and to furnish such additional information as may be deemed necessary for action on the application. (e) If the Commissioner concludes that the variation may be advantageous to consumers and will not result in failure of the food to conform to any provision of the act except section 403 (g), a permit shall be issued to the applicant for interstate shipment of such food. The terms and conditions of the permit shall be those set forth in the application with such modifications, restrictions, or qualifications as the Commissioner may deem necessary and state in the permit. (f) The terms and conditions of the permit may be modified at the discretion of the Commissioner or upon application of the permittee during the effective period of the permit. (g) The Commissioner may revoke a permit for cause, which shall include but not be limited to the following: (1) That the permittee has introduced a food into interstate commerce contrary to the terms and conditions of the permit. (2) That the application for a permit contains an untrue statement of a material fact. (3) That the need therefor no longer exists. (h) During the period within which any permit is effective, it shall be deemed to be included within the terms of any guaranty or undertaking otherwise effective pursuant to the provisions of section 303 (c) of the act. (1) If an application is made for an extension of the permit, it shall be accompanied by a description of experiments conducted under the permit, tentative conclusions reached, and reasons why further experimental shipments are considered necessary. (j) Notice of the granting or revocation of any permit shall be published in the FEDERAL REGISTER. § 10.6 General methods for water ca. pacity and fill of containers. For the purposes of regulations promulgated under section 401 of the act: (a) The term "general method for water capacity of containers” means the following method: (1) In the case of a container with lid attached by double seam, cut out the lid without removing or altering the height of the double seam. (2) Wash, dry, and weigh the empty container. (3) Fill the container with distilled water at 68° Fahrenheit to 3/16 inch vertical distance below the top level of the container, and weigh the container thus filled. (4) Subtract the weight found in subparagraph (2) of this paragraph from the weight found in subparagraph (3) of this paragraph. The difference shall be considered to be the weight of water required to fill the container. In the case of a container with lid attached otherwise than by double seam, remove the lid and proceed as directed in subparagraphs (2) to (4) of this paragraph, except that under subparagraph (3) of this paragraph, fill the container to the level of the top thereof. (b) The term "general method for fill of containers" means the following method: (1) In the case of a container with lid attached by double seam, cut out the lid without removing or altering the height of the double seam. (2) Measure the vertical distance from the top level of the container to the top level of the food. (3) Remove the food from the container; wash, dry, and weigh the container. (4) Fill the container with water to 16 inch vertical distance below the top level of the container. Record the temperature of the water, weigh the container thus filled, and determine the weight of the water by subtracting the weight of the container found in subparagraph (3) of this paragraph. (5) Maintaining the water at the temperature recorded in subparagraph (4) of this paragraph, draw off water from the container as filled in subparagraph (4) of this paragraph to the level of the food found in subparagraph (2) of this paragraph, weigh the container with remaining water, and determine the weight of the remaining water by subtracting the weight of the container found in subparagraph (3) of this paragraph. (6) Divide the weight of water found in subparagraph (5) of this paragraph by the weight of water found in subparagraph (4) of this paragraph, and multiply by 100. The result shall be considered to be the percent of the total capacity of the container occupied by the food. In the case of a container with lid attached otherwise than by double seam, remove the lid and proceed as directed in subparagraphs (2) to (6) of this paragraph, except that under subparagraph (4) of this paragraph, fill the container to the level of the top thereof. § 10.7 General statements of substandard quality and substandard fill of container. For the purposes of regulations promulgated under section 401 of the act: (a) The term "general statement of substandard quality" means the statement "Below Standard in Quality Good Food-Not High Grade" printed in two lines of Cheltenham bold condensed caps. The words "Below Standard in Quality" constitute the first line, and the second immediately follows. If the quantity of the contents of the container is less than 1 pound, the type of the first line is 12point, and of the second, 8-point. If such quantity is 1 pound or more, the type of the first line is 14-point, and of the second, 10-point. Such statement is enclosed within lines, not less than 6 points in width, forming a rectangle. Such statement, with enclosing lines, is on a strongly contrasting, uniform background, and is so placed as to be easily seen when the name of the food or any pictorial representation thereof is viewed, wherever such name or representation appears so conspicuously as to be easily seen under customary conditions of purchase. If (b) The term "general statement of substandard fill" means the statement "Below Standard in Fill" printed in Cheltenham bold condensed caps. the quantity of the contents of the container is less than 1 pound, the statement is in 12-point type; if such quantity is 1 pound or more, the statement is in 14-point type. Such statement is enclosed within lines, not less than 6 points in width, forming a rectangle; but if the statement specified in paragraph (a) of this section is also used, both statements (one following the other) may be enclosed within the same rectangle. Such statement or statements, with enclosing lines, are on a strongly contrasting, uniform background, and are so placed as to be easily seen when the name of the food or any pictorial representation thereof is viewed, wherever such name or representation appears so conspicuously as to be easily seen under customary conditions of purchase. Sec. 14.1 14.2 14.3 14.4 14.5 14.6 14.7 14.8 PART 14-CACAO PRODUCTS Cacao nibs, cocoa nibs, cracked cocoa; identity; label statement of optional ingredients. Chocolate liquor, chocolate, baking chocolate, bitter chocolate, cooking chocolate, chocolate coating, bitter chocolate coating; identity; label statement of optional ingredients. Breakfast cocoa, high fat cocoa; identity; label statement of optional ingredients. Cocoa, medium fat cocoa; identity; Low-fat cocoa; identity; label state- Milk chocolate, sweet milk chocolate, milk chocolate coating, sweet milk chocolate coating; identity; label statement of optional ingredients. Skim milk chocolate, sweet skim milk chocolate, skim milk chocolate coating, sweet skim milk chocolate coating; identity; label statement of optional ingredients. Buttermilk chocolate, buttermilk chocolate coating; identity; label statement of optional ingredients. 14.10 Mixed dairy product chocolates, mixed dairy product chocolate coatings; identity; label statement of optional ingredients. 14.9 14.11 Sweet chocolate and vegetable fat (other than cacao fat) coating; identity; label statement of optional ingredients. 14.12 Sweet cocoa and vegetable fat (other than cacao fat) coating; identity; label statement of optional ingredients. 14.18 Milk chocolate and vegetable fat (other than cacao fat) coating, sweet milk chocolate and vegetable fat (other than cacao fat) coating; identity; label statement of optional ingredients. AUTHORITY: The provisions of this Part 14 issued under secs. 401, 701, 52 Stat. 1046, as amended, 1055, as amended; 21 U.S.C. 341, 371. SOURCE: The provisions of this Part 14 appear at 20 F.R. 9567, Dec. 20, 1955, unless otherwise noted. § 14.1 Cacao nibs, cocoa nibs, cracked cocoa; identity; label statement of optional ingredients. (a) Cacao nibs, cocoa nibs, cracked cocoa is the food prepared by heating and cracking dried or cured and cleaned cacao beans and removing shell therefrom. Cacao nibs or the cacao beans from which they are prepared may be processed by heating with one or more of the following optional alkali ingredients, added as such or in aqueous solution: Bicarbonate, carbonate, or hydroxide of sodium, ammonium, or potassium; or carbonate or oxide of magnesium; but for each 100 parts by weight of cacao nibs used, as such or before shelling from the cacao beans, the total quantity of such alkalis used is not greater in neutralizing value (calculated from the respective combining weights of such alkalis used) than the neutralizing value of 3 parts by weight of anhydrous potassium carbonate. The cacao shell content of cacao nibs is not more than 1.75 percent by weight (calculated to an alkali-free basis if they or the cacao beans from which they were prepared have been processed with alkali), as determined by the method prescribed under "Shell in Cacao Nibs-Tentative" beginning on page 208 [Ed. note, 10th edition, 1965, p. 180, secs. 12.009-12.013] of "Official and Tentative Methods of Analysis of the Association of Official Agricultural Chemists," 5th Ed., 1940. (b) When cacao nibs or the cacao beans from which they are prepared are processed, in whole or in part, with any optional alkali ingredient specified in paragraph (a) of this section, the label shall bear the statement "Processed with Alkali"; but in lieu of the word "Alkali" in such statement the specific common name of the optional alkali ingredient may be used. Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, such statement shall immediately and conspicuously precede or follow such name without intervening written, printed, or graphic matter. added in quantities needed to adjust the cacao fat content of the finished chocolate liquor. (For the purposes of this section the term "cocoa" means breakfast cocoa, cocoa, low-fat cocoa, or any mixture of two or more of these.) Chocolate liquor may be spiced, flavored, or otherwise seasoned with one or more of the following optional ingredients, other than any such ingredient or combination of ingredients specified in subparagraphs (1), (2), or (3) of this paragraph which imparts a flavor that imitates the flavor of chocolate, milk, or butter: (1) Ground spice. (2) Ground vanilla beans; any natural food flavoring oil, oleoresin, or extract. (3) Vanillin, ethyl vanillin, or other artificial food flavoring. (4) Butter, milk fat, dried malted cereal extract, ground coffee, ground nut meats. (5) Salt. Any optional ingredient used with the cacao beans or cacao nibs from which such chocolate liquor is prepared, or used with any cocoa added in preparing such chocolate liquor, shall be considered to be an optional ingredient used with such chocolate liquor. The optional alkali ingredients specified for use with cacao nibs in § 14.1(a) may be used as optional ingredients with chocolate liquor; but for each 100 parts by weight of cacao nibs used in preparing the chocolate liquor, the total quantity of such alkalis used is not greater in neutralizing value (calculated from the respective combining weights of such alkalis used) than 3 parts by weight of anhydrous potassium carbonate. The finished chocolate liquor contains not less than 50 percent and not more than 58 percent by weight of cacao fat. Unless the chocolate liquor is seasoned with butter, milk fat, or ground nut meats, the percentage of cacao fat is determined by the method prescribed under "Fat Method I-Official" beginning on page 202 [Ed. note, 10th edition, 1965, p. 184, sec. 12.022] of "Official and Tentative Methods of Analysis of the Association of Official Agricultural Chemists," 5th Ed., 1940. (b) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the statements pre scribed in this section, showing the optional ingredients used shall immediately and conspicuously precede or follow such name, without intervening written, printed, or graphic matter: (1) When the food is seasoned with an optional ingredient specified in subparagraph (a) (1) of this section the label shall bear the statement "Spiced," "Spice Added," "With Added Spice,' "Spiced With or "With Added ," the blank being filled in with the specific common name of the spice used. (2) When the food is flavored with an optional ingredient specified in paragraph (a) (2) of this section, the label shall bear the statement "Flavored," "Flavoring Added," "With Added Flavoring," "Flavored With Added," or "With Added "the blank being filled in with the specific common name of the flavoring used. 99 ་་ (5) When any optional alkali ingredient specified in § 14.1 (a) is used, the label shall bear the statement "Processed With Alkali"; but in lieu of the word “Alkali” in such statement the specific common name of the optional alkali ingredient may be used. Label statements prescribed in subpuragraphs (1) to (4), inclusive, of this paragraph may be combined, as for example, "With Added Cinnamon, Vanilla, and Ethyl Vanillin, an Artificial Flavoring." § 14.3 Breakfast cocoa, high fat cocoa; identity; label statement of optional ingredients. (a) Breakfast cocoa, high fat cocoa is the food prepared by pulverizing the residual material remaining after part of (4) Salt. Any optional ingredient used with the cacao beans, cacao nibs, or ground cacao nibs from which such breakfast cocoa is prepared shall be considered to be an optional ingredient used with such breakfast cocoa. The optional alkali ingredients specified for use with cacao nibs in § 14.1 (a) may be used as optional ingredients with breakfast cocoa; but for each 100 parts by weight of cacao nibs used in preparing the breakfast cocoa, the total quantity of such alkalis used is not greater in neutralizing value (calculated from the respective combining weights of such alkalis used) than 3 parts by weight of anhydrous potassium carbonate. The finished breakfast cocoa contains not less than 22 percent of cacao fat, as determined by the method prescribed under "Fat Method I-Offcial" beginning on page 202 [Ed. note, 10th edition, 1965, p. 184, sec. 12.22] of "Official and Tentative Methods of Analysis of the Association of Official Agricultural Chemists," 5th Ed., 1940. (b) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the statements prescribed in this section, showing the optional ingredients used shall immediately and conspicuously precede or follow such name, without intervening written, printed, or graphic matter: (1) When the food is seasoned with an optional ingredient specified in paragraph (a)(1) of this section, the label shall bear the statement "Spiced," "Spice Added," "With Added Spice," "Spiced With," or "With Added ----," the blank being filled in with the specific common name of the spice used. (2) When the food is flavored with an optional ingredient specified in subparagraph (a) (2) of this section, the label shall bear the statement "Flavored," |