Label statements prescribed by subparagraphs (1) to (4), inclusive, of this paragraph may be combined, as for example, "With Added Cinnamon, Vanilla, and Ethyl Vanillin, an Artificial Flavoring."

§ 14.4 Cocoa, medium fat cocoa; identity; label statement of optional ingredients.

Cocoa, medium fat cocoa conforms to the definition and standard of identity, and is subject to the requirements for label statement of optional ingredients, prescribed for breakfast cocoa by § 14.3, except that it contains less than 22 percent but not less than 10 percent of cacao fat, as determined by the method referred to in § 14.3(a).

§ 14.5 Low-fat cocoa; identity; label statement of optional ingredients. Low-fat cocoa conforms to the definition and standard of identity, and is subject to the requirements for label statement of optional ingredients, prescribed for breakfast cocoa by § 14.3, except that it contains less than 10 percent of cacao fat as determined by the method referred to in § 14.3(a).

§ 14.6 Sweet chocolate, sweet chocolate coating; identity; label statement of optional ingredients.

(a) Sweet chocolate, sweet chocolate coating is the solid or semiplastic food the ingredients of which are intimately mixed and ground, prepared from chocolate liquor (with or without the addition of cacao fat) sweetened with one of the optional saccharine ingredients specified in paragraph (b) of this section. It may be spiced, flavored, or otherwise seasoned with one or more of the optional ingredients specified in paragraph (c) of this section, other than any such ingredient or combination of ingredients which imparts a flavor that imitates the flavor of chocolate, milk, or butter. One of the optional emulsifying ingredients or combinations of ingredients specified in paragraph (d) of this section may be used, subject to the conditions therein prescribed. One or more of the optional dairy ingredients specified in paragraph (e) of this section may be used in such quantity that the finished sweet chocolate contains less than 12 percent by weight of milk constituent solids. If chocolate liquor with any optional ingredient specified in § 14.2(a) is used, such ingredient shall be considered to be an optional in

gredient used with the sweet chocolate. The finished sweet chocolate contains not less than 15 percent by weight of chocolate liquor, calculated by subtracting from the weight of chocolate liquor used the weight of cacao fat therein and the weights therein of alkali and seasoning ingredients, if any, multiplying the remainder by 2.2, dividing the result by the weight of the finished sweet chocolate, and multiplying the quotient by 100. Bittersweet chocolate is sweet chocolate which contains not less than 35 percent by weight of chocolate liquor, calculated in the same manner.

(b) The optional saccharine ingredients referred to in paragraph (a) of this section are:

(1) Sugar, or partly refined cane sugar, or both.

(2) Any mixture of dextrose and sugar or partly refined cane sugar or both in which the weight of the solids of the dextrose used is not more than one-third of the total weight of the solids of all the saccharine ingredients used.

(3) Any mixture of dried corn sirup or dried glucose sirup and sugar or partly refined cane sugar or both in which the weight of the solids of the dried corn sirup or dried glucose sirup used is not more than one-fourth of the total weight of the solids of all the saccharine ingredients used.

(4) Any mixture of dextrose and dried corn sirup or dried glucose sirup and sugar or partly refined cane sugar or both in which three times the weight of the solids of the dextrose used plus four times the weight of the solids of the dried corn sirup or of the solids of the dried glucose sirup used is not more than the total weight of the solids of all the saccharine ingredients used.

(c) The optional ingredients for spicing, flavoring, or otherwise seasoning referred to in paragraph (a) of this section are:

(1) Ground spice.

(2) Ground vanilla beans; any natural food flavoring oil or oleoresin or extract. (3) Ground coffee.

(4) Ground nut meats.

(5) Honey, molasses, brown sugar, maple sugar.

(6) Dried malted cereal extract.
(7) Salt.

(8) Vanillin, ethyl vanillin, or other artificial food flavoring.

(d) The optional emulsifying ingredient or combination of ingredients re

ferred to in paragraph (a) of this section is:

(1) Lecithin, with or without related natural phosphatides, in an amount not to exceed 0.5 percent by weight of the finished food (with or without a vegetable food fat carrier in an amount not to exceed two-thirds of the weight of the emulsifying ingredient used); or

(2) Monoglycerides and diglycerides of fat-forming fatty acids in combination with monosodium phosphate derivatives thereof, in an amount not to exceed 0.5 percent of the weight of the finished food (with or without a vegetable food fat carrier in an amount not to exceed two-thirds of the weight of the emulsifying ingredient used); or

(3) Sorbitan monostearate, complying with the requirements of § 121.1029 of this chapter, in an amount not to exceed 1 percent of the weight of the finished food; or

(4) Polysorbate 60, complying with the requirements of § 121.1030 of this chapter, in an amount not to exceed 0.5 percent of the weight of the finished food; or

(5) Any combination of two or more of the foregoing each within the limits prescribed in subparagraphs (1), (2), (3), and (4) of this paragraph provided that the total quantity of any two or all three of the emulsifiers specified in subparagraphs (2), (3), and (4) of this paragraph does not exceed 1 percent by weight of the finished food and the total quantity of the emulsifiers specified in subparagraphs (1) and (2) of this paragraph does not exceed 0.5 percent of the weight of the finished food.

(e) The optional dairy ingredients referred to in paragraph (a) of this section

are:

(1) Cream, milk fat, butter.

(2) Milk, concentrated milk, evaporated milk, sweetened condensed milk, dried milk.

(3) Skim milk, concentrated skim milk, evaporated skim milk, sweetened condensed skim milk, nonfat dry milk. (4) Concentrated buttermilk, dried buttermilk.

(5) Malted milk.

(f) For the purpose of this section:

(1) The term "dextrose" means the anhydrous refined monosaccharide obtained from hydrolyzed starch.

(2) The term "dried corn sirup" means the product obtained by drying incompletely hydrolyzed cornstarch; its solids

contain not less than 40 percent by weight of reducing sugars calculated as anhydrous dextrose.

(3) The term "dried glucose sirup" means the product obtained by drying "glucose sirup." "Glucose sirup" is a clarified, concentrated, aqueous solution of the products obtained by the incomplete hydrolysis of any edible starch. The solids of glucose sirup contain not less than 40 percent by weight of reducing sugars calculated as anhydrous dextrose.

(g) "Semisweet chocolate," "bittersweet chocolate," "semisweet chocolate coating," and "bittersweet chocolate coating" are alternate names for sweet chocolate which contains not less than the minimum quantity of chocolate liquor prescribed for bittersweet chocolate by paragraph (a) of this section.

(h) 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 paragraph 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 flavored with an optional ingredient specified in paragraph (c) (8) of this section, the label shall bear the statement "Artificially flavored," "Artificial flavoring added," "With artificial flavoring," "Artificially flavored with or "With an artificial flavoring," the blank being filled in with the specific common name of the artificial flavoring used.

111)

(2) When an optional emulsifying ingredient or combination of ingredients specified in paragraph (d) of this section is used, the label shall bear the statement "Emulsifier added," "With added emulsifier," or added as

66

(an) emulsifier (s)," the blank being filled in with the common name(s) of the emulsifier(s) used.

(3) When any optionai 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.

In cases where two or more of the statements set forth in this paragraph are required, such statements may be com

bined in a manner which is appropriate and not misleading.

[33 F.R. 4656, Mar. 19, 1968]

§ 14.7 Milk chocolate, sweet milk chocolate, milk chocolate coating, sweet milk chocolate coating; identity; label statement of optional ingredi

ents.

(a) Milk chocolate, sweet milk chocolate, milk chocolate coating, sweet milk chocolate coating is the solid or semiplastic food the ingredients of which are intimately mixed and ground, prepared from chocolate liquor (with or without the addition of cacao fat) and one or more of the optional dairy ingredients specified in paragraph (b) of this section, sweetened with one of the optional saccharine ingredients specified in § 14.6 (b) and (f). It may be spiced, flavored, or otherwise seasoned with one or more of the optional ingredients specified in paragraph (c) of this section, other than any such ingredient or combination of ingredients which imparts a flavor that imitates the flavor of chocolate, milk, or butter. One of the optional emulsifying ingredients or combinations of ingredients specified in paragraph (d) of this section may be used, subject to the conditions therein prescribed. If chocolate liquor with any optional ingredient specified in § 14.2(a) is used, such ingredient shall be considered to be an optional ingredient used with the milk chocolate. The finished milk chocolate contains not less than 3.66 percent by weight of milk fat, not less than 12 percent by weight of milk solids, and not less than 10 percent by weight of chocolate liquor as calculated by subtracting from the weight of chocolate liquor used the weight of cacao fat therein and the weights therein of alkali and seasoning ingredients, if any, multiplying the remainder by 2.2, dividing the result by the weight of the finished milk chocolate, and multiplying the quotient by 100.

(b) The optional dairy ingredients referred to in paragraph (a) of this section are milk, concentrated milk, evaporated milk, sweetened condensed milk, dried milk, butter, milk fat, cream, skim milk, concentrated skim milk, evaporated skim milk, sweetened condensed skim milk, and nonfat dry milk; but in any such ingredient or combination of two or more of such ingredients used, the weight of nonfat milk solids is not more than 2.43 times and not less than 1.20 times the weight of milk fat therein.

(2) Ground vanilla beans; any natural food flavoring oil or oleoresin or extract. (3) Ground coffee.

(4) Ground nut meats.

(5) Honey, molasses, brown sugar, maple sugar.

(6) Dried malted cereal extract.
(7) Salt.

(8) Vanillin, ethyl vanillin, or other artificial food flavoring.

(d) The optional emulsifying ingredient or combination of ingredients referred to in paragraph (a) of this section is:

(1) Lecithin, with or without related natural phosphatides, in an amount not to exceed 0.5 percent by weight of the finished food (with or without a vegetable food fat carrier in an amount not to exceed two-thirds of the weight of the emulsifying ingredient used); or

(2) Monoglycerides and diglycerides of fat-forming fatty acids in combination with monosodium phosphate derivatives thereof, in an amount not to exceed 0.5 percent of the weight of the finished food (with or without a vegetable food fat carrier in an amount not to exceed two-thirds of the weight of the emulsifying ingredient used); or

(3) Sorbitan monostearate, complying with the requirements of § 121.1029 of this chapter, in an amount not to exceed 1 percent of the weight of the finished food; or

(4) Polysorbate 60, complying with the requirements of § 121.1020 of this chapter, in an amount not to exceed 0.5 percent of the weight of the finished food; or

(5) Any combination of two or more of the foregoing each within the limits prescribed in subparagraphs (1), (2), (3), and (4) of this paragraph provided that the total quantity of any two or all three of the emulsifiers specified in subparagraphs (2), (3), and (4) of this paragraph does not exceed 1 percent by weight of the finished food and the total quantity of the emulsifiers specified in subparagraphs (1) and (2) of this paragraph does not exceed 0.5 percent of the weight of the finished food.

(e) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary con

(a) (1) General. Any lake inade by extending on a substratum of alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate, or on any combination of two or more of these (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.

Sec.

10.1 10.2

PART 10-DEFINITIONS AND STANDARDS FOR FOOD

Definitions and interpretations. 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.

(a) The definitions and interpret tions of terms contained in section of the act shall be applicable also to su terms when used in regulations promu gated under the act.

(b) If a regulation prescribing a def nition and standard of identity for food has been promulgated under sectic 401 of the act and the name there specified for the food is used in any othe regulation under section 401 or any othe provision of the act, such name mean the food which conforms to such defin tion and standard, except as otherwis specifically provided in such other regu lation.

(c) No provision of any regulatio prescribing a definition and standard d identity or standard of quality or fill container under section 401 of the ac shall be construed as in any way affecting the concurrent applicability of the general provisions of the act and the regulations thereunder relating to adul teration and misbranding. For example all regulations under section 401 contemplate that the food and all articles used as components or ingredient thereof shall not be poisonous or dele terious and shall be clean, sound, and fit for food. A provision in such regula.

s for the use of coloring or flavoring not authorize such use under cirstances or in a manner whereby age or inferiority is concealed or reby the food is made to appear betor of greater value than it is.

2 Procedure for establishing_food standards under the Federal Food, Drug, and Cosmetic Act.

ection 401 of the Federal Food, Drug, Cosmetic Act provides for the foration of definitions and standards of tity and standards of quality and fill ontainer for foods. This procedure ndensed as follows:

> If the petitioner shows that he is nterested person and furnishes reable grounds for his proposal, it is duty of the Commissioner to publish proposal and afford opportunity for r interested persons to comment on fter a study of all the facts availand of the comments received, the missioner will act upon the proposal publish an order, to which objection be taken by persons who would be rsely affected. Thus the issues in roversy are singled out for a public ing.

) Practical administration of the requires that there be a substantial ving of merit before any proposal is ished. In passing on proposals subed by petitioners for initiating acs, it will be the policy of the Food Drug Administration to consider reasonable grounds have been fured when:

) The proposal includes or is acpanied by a statement of the facts - the petitioner asserts he is in a tion to substantiate by evidence in event the proceedings lead to a pubhearing.

) The facts declared furnish subtial support of the proposal and cant a conclusion that the proposal asonable.

) The proposal, if adopted, would note honesty and fair dealing in the rest of consumers.

› Opportunity will be given to nd petitions regarded as inadequate. 1) At any time prior to the issuance n order acting on his proposal under ion 701(e) (1) of the act, the petier may withdraw his petition withprejudice 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.