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(1) one of the straight colors hereinbefore listed in this subpart, which color is a salt in which is combined the basic radical sodium, potassium, barium, or calcium; or (ii) a salt prepared from one of the straight colors hereinbefore listed in this subpart by combining such color with the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium.

(2) Specifications.

Ether extracts, not more than 0.5 percent.

Soluble chlorides and sulfates (as sodium salts), not more than 3.0 percent. Intermediates, not more than 0.2

percent.

(b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows:

(1) The listed name of the color from which the lake is prepared;

(2) The name of the basic radical combined in such color; and

(3) The word "Lake."

(For example, the name of a lake prepared by extending the color Ext D&C Yellow No. 2 upon a substratum is "Ext D&C Yellow No. 2-Calcium Lake," and a lake prepared by extending the barium salt prepared from Ext D&C Red No. 2 upon the substratum is "Ext D&C Red No. 2-Barium Lake.")

SUBCHAPTER B-FOOD AND FOOD PRODUCTS

PART 10-DEFINITIONS AND STANDARDS FOR FOOD

10.1 Definitions and interpretations. 10.2 Procedure for establishing food standards under the Federal Food, Drug, and Cosmetic Act.

10.3 Conformity to definitions and standards of identity.

10.4 Food additives proposed for use in foods for which definitions and standards of identity are established. 10.5 Temporary permits for interstate shipment of experimental packs of food varying from the requirements of definitions and standards of identity. 10.6 General methods for water capacity and fill of containers.

10.7 General statements of substandard quality and substandard fill of container.

AUTHORITY: The provisions of this Part 10 issued under secs. 401, 701, 52 Stat. 1046, 1055 as amended; 21 U.S.C. 341, 371.

SOURCE: The provisions of this Part 10 appear at 27 F.R. 11255, Nov. 15, 1962, unless otherwise noted.

CROSS-REFERENCE: For other regulations in this chapter concerning definitions and standards for foods, see also §§ 3.1, 3.17, 3.38, 5.2, 5.3, 5.4, 121.8 and Parts 14 through 53, inclusive. For other regulations in this chapter concerning procedure for establishing regulations, see also Subpart F of Part 2. $ 10.1 Definitions and interpretations.

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(a) The definitions and interpretations of terms contained in section 201 of the act shall be applicable also to such terms when used in regulations promulgated under the act.

(b) If a regulation prescribing a definition and standard of identity for a food has been promulgated under section 401 of the act and the name therein specified for the food is used in any other regulation under section 401 or any other

provision of the act, such name means the food which conforms to such definition and standard, except as otherwise specifically provided in such other regulation.

(c) No provision of any regulation prescribing a definition and standard of identity or standard of quality or fill of container under section 401 of the act shall be construed as in any way affecting the concurrent applicability of the general provisions of the act and the regulations thereunder relating to adulteration and misbranding. For example, all regulations under section 401 contemplate that the food and all articles used as components or ingredients thereof shall not be poisonous or deleterious and shall be clean, sound, and fit for food. A provision in such regulations for the use of coloring or flavoring does not authorize such use under circumstances or in a manner whereby damage or inferiority is concealed or whereby the food is made to appear better or of greater value than it is. § 10.2 Procedure for establishing_food standards under the Federal Food, Drug, and Cosmetic Act.

Section 401 of the Federal Food, Drug, and Cosmetic Act provides for the formulation of definitions and standards of identity and standards of quality and fill of container for foods. This procedure is condensed as follows:

(a) If the petitioner shows that he is an interested person and furnishes reasonable grounds for his proposal, it is the duty of the Commissioner to publish the proposal and afford opportunity for other interested persons to comment on it. After a study of all the facts available and of the comments received, the Commissioner will act upon the proposal and publish an order, to which objection may be taken by persons who would be adversely affected. Thus the issues in controversy are singled out for a public hearing.

(b) Practical administration of the law requires that there be a substantial showing of merit before any proposal is published. In passing on proposals submitted by petitioners for initiating actions, it will be the policy of the Food and Drug Administration to consider that reasonable grounds have been furnished when:

(1) The proposal includes or is accompanied by a statement of the facts that the petitioner asserts he is in a

position to substantiate by evidence in the event the proceedings lead to a public hearing.

(2) The facts declared furnish substantial support of the proposal and warrant a conclusion that the proposal is reasonable.

(3) The proposal, if adopted, would promote honesty and fair dealing in the interest of consumers.

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(c) Opportunity will be given amend petitions regarded as inadequate. (d) At any time prior to the issuance of an order acting on his proposal under section 701 (e) (1) of the act, the petitioner may withdraw his petition without prejudice to a future filing. Notice of withdrawal of the petition and termination of the rulemaking proceeding will be published in the FEDERAL REGISTER. [27 F.R. 11255, Nov. 15, 1962, as amended at 31 F.R. 7227, May 18, 1966]

§ 10.3

Conformity to definitions and standards of identity.

In the following conditions, among others, a food does not conform to the definition and standard of identity therefor:

(a) If it contains an ingredient for which no provision is made in such definition and standard, unless such ingredient is an incidental additive introduced at a nonfunctional and insignificant level as a result of its deliberate and purposeful addition to another ingredient permitted by the terms of the applicable standard and the presence of such incidental additive in unstandardized foods has been exempted from label declaration as provided in Part 5 of this chapter.

(b) If it fails to contain any one or more ingredients required by such definition and standard;

(c) If the quantity of any ingredient or component fails to conform to the limitation, if any, prescribed therefor by such definition and standard.

[27 F.R. 11255, Nov. 15, 1962, as amended at 30 F.R. 15292, Dec. 10, 1965]

§ 10.4 Food additives proposed for use in foods for which definitions and standards of identity are established. (a) Where a petition is received for the issuance or amendment of a regulation establishing a definition and standard of identity for a food under section 401 of the act, which proposes the inclusion of a food additive in such definition and standard of identity, the provisions

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 deflnition 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 capacity 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

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If

(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. 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.

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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;
label statement of optional in-
gredients.

Low-fat cocoa; identity; label state-
ment of optional ingredients.
Sweet chocolate, sweet chocolate coat-
ing; identity; label statement of
optional ingredients.

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

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