[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1030]
[Page 360]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 73 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of
Subpart B Drugs
Sec. 73.1030 Annatto extract.
(a) Identity and specifications. (1) The color additive annatto
extract shall conform in identity and specifications to the requirements
of Sec. 73.30(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. Annatto extract may be safely used for
coloring drugs generally, including those intended for use in the area
of the eye, 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 Sec. 70.25 of this chapter. Labels
shall bear information showing that the color is derived from annatto
seed. The requirements of Sec. 70.25(a) of this chapter that all
ingredients shall be listed by name shall not be construed as requiring
the declaration of residues of solvents listed in Sec. 73.30(a)(1)(ii)
of this chapter.
(d) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health and
therefore batches thereof are evempt from the certification requirements
of section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 42 FR 36994, July 19, 1977]
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