[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.30]

[Page 341-342]
 
                        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 Contents
 
                            Subpart A--Foods
 
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 
chapter.
    (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.

[[Page 342]]

    (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.