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73.1030 Annatto extract.

Home > Regulations > Listing of color additives exempt from certification > 73.1030 Annatto extract.






[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: 21CFR73.1030]



[Page 358]

 

                        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 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]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 1030


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