[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.30]
 
 [Page 346-347]
 
                         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
 
 [[Page 347]]
 
 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.
     (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.