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73.30 Annatto extract.

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[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR73.30]

[Page 339-340]


                        TITLE 21--FOOD AND DRUGS






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

[[Page 340]]

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:

Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 30

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