§ 8.6001 Synthetic iron oxide.

(a) Identity. (1) The color additive synthetic iron oxide consists of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It is free from admixture with other substances.

(2) Color additive mixtures for drug use made with synthetic iron oxide may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring drugs.

(b) Specifications. Synthetic iron oxide shall conform to the following specifications, all on an "as is" basis:

Arsenic (as As), not more than 3 parts per million.

Lead (as Pb), not more than 10 parts per million.

Mercury (as Hg), not more than 3 parts per million.

(c) Uses and restrictions. The color additive synthetic iron oxide may be safely used to color ingested or topically applied drugs generally subject to the restriction that if the color additive is used in drugs ingested by man the amount consumed in accordance with labeled or prescribed dosages shall not exceed 5 milligrams, calculated as elemental iron, per day.

(d) Labeling requirements. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of § 8.32.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification requirements of section 706(c) of the act. [31 F.R. 2653, Feb. 11, 1966] § 8.6002 Caramel.

(1)

(a) Identity and specifications. The color additive caramel shall conform in identity and specifications to the requirements of § 8.303 (a) (1), (2), and (3) and (b).

(2) The diluents in color additive mixtures for drug use containing caramel shall be limited to those listed in this subpart F as safe and suitable in color additive mixtures for coloring drugs.

(b) Uses and restrictions. Caramel may be used for coloring ingested and topically applied drugs generally in amounts consistent with good manufacturing practice.

(c) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirement of section 706(c) of the act. [28 F.R. 8309, Aug. 14, 1963]

§ 8.6003 Annatto extract.

(a) Identity and specifications. (1) The color additive annatto extract shall conform in identity and specifications to the requirements of § 8.305(a)(1) and (b).

(2) Color additive mixtures for drug use made with annatto extract may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring ingested drugs.

(b) Uses and restrictions. The color additive annatto extract may be used for coloring ingested drugs generally in amounts consistent with good manufacturing practice.

(c) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 8.32. Labels shall bear information showing that the color is derived from annatto seed. The requirements of § 8.32(a) that all ingredients shall be listed by name shall not be construed as requiring the declaration of residues of solvents listed in § 8.305 (a) (1) (ii).

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [33 F.R. 8815, June 18, 1968]

§ 8.6004 B-Carotene.

(a) Identity and specifications. (1) The color additive B-carotene shall conform in identity and specifications to the requirements of § 8.304 (a) (1) and (b).

(2) The diluents in color additive mixtures for drug use containing B-carotene are limited to those listed in Subpart F of this Part 8 as safe and suitable in color additive mixtures for coloring ingested drugs.

(b) Uses and restrictions. B-Carotene may be used for coloring ingested drugs generally in amounts consistent with good manufacturing practice.

(c) Labeling requirements. The la

beling of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of § 8.32.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the Act. [29 F.R. 3003, Mar. 5, 1964]

§ 8.6005 Titanium dioxide.

(a) Identity and specifications. (1) The color additive titanium dioxide shall conform in identity and specifications to the requirements of § 8.316 (a) (1) and (b).

(2) Color additive mixtures for drug use made with titanium dioxide may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring drugs, and the following: Silicon dioxide, SiO2, and/or aluminum oxide, Al,O,, as dispersing aids-not more than 2 percent total.

(b) Uses and restrictions. The color additive titanium dioxide may be used for coloring ingested and externally applied drugs generally, in amounts consistent with good manufacturing practice. External application includes use in the area of the eye.

(c) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 8.32.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [33 F.R. 8815, June 18, 1968]

§ 8.6006 Pyrophyllite.

(a) Identity. (1) The color additive pyrophyllite is a naturally occurring mineral substance consisting predominantly of a hydrous aluminum silicate, Al2O3 4SiO2 H2O, intimately mixed with lesser amounts of finely divided silica, SiO2. Small amounts, usually less than 3 percent, of other silicates, such as potassium aluminum silicate, may be present. Pyrophyllite may be identified and semiquantitatively determined by its characteristic X-ray powder diffraction pattern and by its optical properties.

(2) Color additive mixtures made with pyrophyllite are limited to those listed in this Subpart F as safe and suitable in color additive mixtures for coloring externally applied drugs.

(b) Specifications. Pyrophyllite shall conform to the following specifications: Lead (as Pb), not more than 20 parts per million.

Arsenic (as As), not more than 3 parts per million.

Lead and arsenic shall be determined in the solution obtained by boiling 10 grams of the pyrophyllite for 15 minutes in 50 milliliters of 0.5N hydrochloric acid.

(c) Uses and restrictions. Pyrophyllite may be safely used in amounts consistent with good manufacturing practice to color drugs that are to be externally applied.

(d) Labeling requirements. The labeling of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 8.32.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [31 F.R. 5070, Mar. 29, 1966]

§ 8.6009 Cochineal extract; carmine.

(a) Identity and specifications. (1) The color additives cochineal extract and carmine shall conform in identity and specifications to the requirements of § 8.317(a) (1) and (2) and (b).

(2) Color additive mixtures for drug use made with carmine and cochineal extract may contain only those diluents that are suitable and that are listed in this Subpart F as safe in color additive mixtures for coloring drugs.

(b) Uses and restrictions. Cochineal extract and carmine may be safely used for coloring ingested and externally applied drugs in amounts consistent with good manufacturing practice.

(c) Labeling requirements. The label of the color additives and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of § 8.32.

(d) Exemption from certification. Certification of these color additives is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706 (c) of the act. [33 F.R. 18578, Dec. 14, 1968]

(a) Identity. (1) The color additive alumina (dried aluminum hydroxide) is a white, odorless, tasteless, amorphous powder consisting essentially of aluminum hydroxide (Al2O, X H2O).

(2) Color additive mixtures for drug use made with alumina (dried aluminum hydroxide) may contain only those diluents listed in this Subpart F as safe and suitable for use in color additive mixtures for coloring drugs.

(b) Specifications. Alumina (dried aluminum hydroxide) shall conform to the following specifications:

Acidity or alkalinity: Agitate 1 gram of the color additive with 25 milliliters of water and filter. The filtrate shall be neutral to litmus paper.

Matter insoluble in dilute hydrocholric acid, not more than 0.5 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Mercury (as Hg), not more than 1 part per million.

Aluminum oxide (Al,O,), not less than 50 percent.

(c) Uses and restrictions. Alumina (dried aluminum hydroxide) may be safely used in amounts consistent with good manufacturing practice to color drugs generally.

(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 8.32.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [32 F.R. 6686, May 2, 1967]

§ 8.6012 Calcium carbonate.

(a) Identity. (1) The color additive calcium carbonate is a fine, white, synthetically prepared powder consisting essentially of precipitated calicum carbonate (CaCO3).

(2) Color additive mixtures for drug use made with calcium carbonate may contain only those diluents listed in this Subpart F as safe and suitable for use in color additive mixtures for coloring drugs.

(b) Specifications. Calcium carbonate shall meet the specifications for pre

cipitated calcium carbonate in the U.S.P. (c) Uses and restrictions. Calcium carbonate may be safely used in amounts consistent with good manufacturing practice to color drugs generally.

(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 8.32.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [32 F.R. 6686, May 2, 1967]

(a) Identity. (1) The color additive talc is a finely powdered, native, hydrous magnesium silicate sometimes containing a small proportion of aluminum silicate.

(2) Color additive mixtures for drug use made with talc may contain only those diluents listed in this Subpart Fas safe and suitable for use in color additive mixtures for coloring drugs.

(b) Specifications. Talc shall meet the specifications for talc in the U.S.P. and the following:

Lead (as Pb), not more than 20 parts per million.

Arsenic (as As), not more than 3 parts per million.

Lead and arsenic shall be determined in the solution obtained by boiling 10 grams of the talc for 15 minutes in 50 milliliters of 0.5N hydrochloric acid.

(c) Uses and restrictions. Talc may be safely used in amounts consistent with good manufacturing practice to color drugs generally.

(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 8.32.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [32 F.R. 6686, May 2, 1967]

§ 8.6014 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex).

(a) Identity. (1) The color additive potassium sodium copper chlorophyllin is a green to black powder obtained from

chlorophyll by replacing the methyl and phytyl ester groups with alkali and replacing the magnesium with copper. The source of the chlorophyll is dehydrated alfalfa.

(2) Color additive mixtures for drug use made with potassium sodium copper chlorophyllin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring drugs.

(b) Specifications. Potassium sodium copper chlorophyllin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:

Moisture, not more than 5.0 percent. Nitrogen, not more than 5.0 percent. pH of 1 percent solution, 9 to 11.

Total copper, not less than 4 percent and not more than 6 percent.

Free copper, not more than 0.25 percent.
Iron, not more than 0.5 percent.

Lead (as Pb), not more than 20 parts per million.

Arsenic (as As), not more than 5 parts per million.

Ratio, absorbance at 405 mu to absorbance at 630 mp, not less than 3.4 and not more than 3.9.

Total color, not less than 75 percent.

(c) Uses and restrictions. Potassium sodium copper chlorophyllin may be safely used for coloring dentifrices that are drugs at a level not to exceed 0.1 percent. Authorization for this use shall not be construed as waiving any of the requirements of section 505 of the act with respect to the drug in which it is used.

(d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 8.32.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 706 (c) of the act.

[34 F.R. 6975, Apr. 26, 1969; 34 F.R. 9795, June 25, 1969]

(2) Color additive mixtures for ingested drug use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring ingested drugs.

(b) Uses and restrictions. Canthaxanthin may be safely used for coloring ingested drugs generally in amounts consistent with good manufacturing practice.

(c) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 8.32.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706 (c) of the act. [34 F.R. 250, Jan. 8, 1969]

Subpart G-Listing of Color Additives for Cosmetic Use Subject to Certification [Reserved]

Subpart H-Listing of Color Additives for Cosmetic Use Exempt From Certification

§ 8.8002 Henna.

(a) Identity. The color additive henna is the dried leaf and petiole of Lawsonia alba Lam. (Lawsonia inermis L.). It may be identified by its characteristic odor and by characteristic plant histology.

(b) Specifications. Henna shall conform to the following specifications:

It shall not contain more than 10 percent of plant material from Lawsonia alba Lam. (Lawsonia inermis L.) other than the leaf and petiole, and shall be free from admixture with material from any other species of plant.

Moisture, not more than 10 percent.
Total ash, not more than 15 percent.
Acid-insoluble ash, not more than 5 percent.
Lead (as Pb), not more than 20 parts per
million.

Arsenic (as As), not more than 3 parts per million.

(c) Uses and restrictions. The color additive henna may be safely used for coloring hair only. It may not be used for coloring the eyelashes or eyebrows, or generally in the area of the eye.

(d) Labeling. The label for henna shall bear the information required by § 8.32

§ 8.8004

Potassium sodium copper chlorophyllin (chlorophyllin-copper complex).

(a) Identity and specifications. The color additive potassium sodium copper chlorophyllin shall conform in identity and specifications to the requirements of § 8.6014 (a) (1) and (b).

(b) Uses and restrictions. Potassium sodium copper chlorophyllin may be safely used for coloring dentifrices that are cosmetics subject to the following conditions:

(1) It shall not be used at a level in excess of 0.1 percent.

(2) It may be used only in combination with the following substances:

Water.

Glycerin.

Sodium carboxymethylcellulose.

Tetrasodium pyrophosphate.

Sorbitol.

Magnesium phosphate, tribasic.

Calcium carbonate.

Calcium phosphate, dibasic.

Sodium N-lauroyl sarcosinate.

9.159 D&C Red No. 14. 9.162 D&C Red No. 17. 9.164 D&C Red No. 19.

Artificial sweeteners that are generally recognized as safe or that are authorized under Part 121 of this chapter.

Flavors that are generally recognized as safe or that are authorized under Part 121 of this chapter.

Preservatives that are generally recognized as safe or that are authorized under Part 121 of this chapter.

(c) Labeling. The label of the color additive shall conform to the requirements of § 8.32.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [34 F.R. 6976, Apr. 26, 1969]