§ 9.307 Ext D&C Yellow No. 7.

Disodium salt of 2,4-dinitro-1-naphthol-7-sulfonic acid.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 0.2 percent.

Ether extracts, not more than 0.1 percent.

Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Martius yellow, not more than 0.03 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

§ 9.340 Ext D&C Red No. 1.

Disodium salt of 8-acetamido-2-pacetamidophenylazo - 1 - naphthol - 3,6disulfonic acid.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

p-Amino acetanilid, not more than 0.2 percent.

Chlorides and sulfates of sodium, not more than 6.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent.

§ 9.341 Ext D&C Red No. 2.

Trisodium salt of 1-0-carboxyphenylazo-2-naphthol-3,6 disulfonic acid. Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

o-Toluidine, not more than 0.2 percent. Mixed oxides, not more than 1.0 percent.

Chlorides and sulfates of sodium, not more than 10.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 80.0 percent.

§ 9.347 Ext D&C Red No. 8.

Monosodium salt of 4-(2-hydroxy-1naphthylazo) - 1 - naphthalenesulfonic acid.

Volatile matter (at 135° C.), not more than 5.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

B-Naphthol, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 90.0 percent.

§ 9.349 Ext D&C Red No. 10.

Disodium salt of 2-(4-sulfo-1-naphthylazo)-1-naphthol-4-sulfonic acid. Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

§ 9.350 Ext D&C Red No. 11.

Disodium salt of 8-acetamido-2-phenylazo-1-naphthol-3,6-disulfonic acid. Volatile matter (at 135° C.), not more than 5.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Aniline, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 10.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent

§ 9.352 Ext D&C Red No. 13.

Disodium salt of 1-p-phenylazo-phenylazo-2-naphthol-6,8-disulfonic acid. Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Aniline, not more than 0.2 percent. p-Aminoazobenzene, not more than 0.2

percent.

Chlorides and sulfates of sodium, not more than 8.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent.

§ 9.353 Ext D&C Red No. 14.

1-Xylylazo-2-naphthol.

Volatile matter (at 100° C.), not more than 0.5 percent.

Sulfated ash, not more than 0.3 per

cent.

Water-soluble matter, not more than 0.3 percent.

Matter insoluble in carbon tetrachloride, not more than 0.5 percent.

Xylidine, not more than 0.1 percent. B-Naphthol, not more than 0.05 per

cent.

m-Xylidine in xylidine obtained by reduction of the dye, not more than 30.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 97.0 percent.

Boiling range of xylidine, obtained by reduction of the dye, 95 percent between 212°-232° C.

§ 9.354 Ext D&C Red No. 15.

Disodium salts of a mixture of 1-alkylphenylazo-2-naphtho 1-3,6-disulfonic acids, of which the mixture of amines obtained by reduction of the dye shall have the following composition: 1-Amino-2,4,5-trimethylbenzene,

less than 35 percent and not more than 45 percent.

1-Amino-2,4-dimethylbenzene, not less than 30 percent and not more than 40 percent.

1-Amino-2,5-dimethylbenzene, not less than 10 percent and not more than 20 percent.

1-Amino-2,6-dimethylbenzene, not less than 4 percent and not more than 12 percent.

1-Amino-2-ethylbenzene and 1-amino4-ethylbenzene, total not more than 5 percent.

1-Amino-2,3-dimethylbenzene and 1amino-3,4-dimethylbenzene, total not more than 4 percent.

Aniline, toluidines, and 1-amino-2,3,4trimethylbenzene, not more than 1 percent of any individual amine and not more than 1.5 percent total of such amines.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 0.5 percent.

Ether extracts, not more than 0.2 percent.

Uncombined intermediates, not more than 0.2 percent.

Chlorides and sulfates of sodium, not more than 6.0 percent.

Mixed oxides, not more than 1.0 percent.

Lower sulfonated dyes, not more than 2.0 percent.

Pure dye, not less than 85.0 percent. Certificates issued heretofore for the color additive FD&C Red No. 1 and canceled by order (25 F.R. 11214) may be reissued for Ext D&C Red No. 15 (§ 9.354 of this chapter). [26 F.R. 162, Jan. 10, 1961]

§ 9.370 Ext D&C Blue No. 1.

3-Methochloride of 9-dimethylamino3-methylimino-3-isophenothiazine.

Volatile matter (at 110° C.), not more than 16.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Dimethyl aniline, not more than 0.2 percent.

not

Chlorides and sulfates of sodium, not more than 2.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent.

§ 9.373 Ext D&C Blue No. 4.

Disodium salt of 4,8-diamino-1,5-dihydroxy-2,6-anthraquinone disulfonic acid. Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Chlorides and sulfates of sodium, not more than 10.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as calculated from organically combined sulfur or nitrogen), not less than 80.0 percent.

§ 9.400 Ext D&C Green No. 1.

Ferric salt of 6-sodiumsulfo-1-isonitroso-1,2-naphthoquinone.

Volatile matter (at 135° C.), not more than 10.0 percent.

Ether extracts, not more than 0.5 percent.

Water-insoluble matter, not more than 1.0 percent.

Chlorides and sulfates of sodium, not more than 5.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

§ 9.411 Ext D&C Violet No. 2.

Monosodium salt of 1-hydroxy-4-(0sulfo-p-toluino) -anthraquinone.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

p-Toluidine, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 8.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 80.0 percent.

§ 9.420 Ext D&C Orange No. 1.

a -(o-Nitro-p-anisylazo) - o-acetacetotoluide.

Volatile matter (at 135° C.), not more than 2.0 percent.

Sulfated ash, not more than 1.0 per

cent.

Matter insoluble in toluene, not more than 1.0 percent.

2-Nitro-p-anisidine, not more than 0.2

percent.

Pure dye (as determined by titration with titanium trichloride), not less than 96.0 percent.

Melting point, not less than 210° C. § 9.422 Ext D&C Orange No. 3. Monosodium salt of 4-p-sulfophenylazo-1-naphthol.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 0.3 percent.

Ether extracts, not more than 0.2 percent.

a-Naphthol, not more than 0.1 percent. Chlorides and sulfates of sodium, not more than 4.0 percent.

Mixed oxides, not more than 1.0 percent.

Orange II, not more than 5.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 98.0 percent.

Melting point, not less than 128.0° C. § 9.440 Lakes (Ext. D&C).

(a) (1) General. Any lake made 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 (i) 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

Sec.

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.")

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 §§ 1.13, 3.1, 3.17, 3.38, 8.3, 121.8, and Parts 14 through 53, inclusive.

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 avail

able 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.

(c) Opportunity will be given to amend petitions regarded as inadequate. § 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 in