[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table
Sec. 73.30 Annatto extract.
(a) Identity. (1) The color additive annatto extract is an extract
prepared from annatto seed, Bixa orellana L., using any one or an
appropriate combination of the food-grade extractants listed in
paragraph (a)(1) (i) and (ii) of this section:
(i) Alkaline aqueous solution, alkaline propylene glycol, ethyl
alcohol or alkaline solutions thereof, edible vegetable oils or fats,
mono- and diglycerides from the glycerolysis of
edible vegetable oils or fats. The alkaline alcohol or aqueous extracts
may be treated with food-grade acids to precipitate annatto pigments,
which are separated from the liquid and dried, with or without
intermediate recrystallization, using the solvents listed under
paragraph (a)(1)(ii) of this section. Food-grade alkalis or carbonates
may be added to adjust alkalinity.
(ii) Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl
alcohol, methylene chloride, trichloroethylene.
(2) Color additive mixtures for food use made with annatto extract
may contain only diluents that are suitable and that are listed in this
subpart as safe in color additive mixtures for coloring foods.
(b) Specifications. Annatto extract, including pigments precipitated
therefrom, shall conform to the following specifications:
(1) Arsenic (as As), not more than 3 parts per million; lead as Pb,
not more than 10 parts per million.
(2) When solvents listed under paragraph (a)(1)(ii) of this section
are used, annatto extract shall contain no more solvent residue than is
permitted of the corresponding solvents in spice oleoresins under
applicable food additive regulations in parts 170 through 189 of this
(c) Uses and restrictions. Annatto extract may be safely used for
coloring foods generally, in amounts consistent with good manufacturing
practice, except that it may not be used to color foods for which
standards of identity have been promulgated under section 401 of the act
unless added color is authorized by such standards.
(d) 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 paragraph (a)(1)(ii)
of this section.
(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 721(c) of the act.
Additives that reference this regulation: