[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR589.1000]

[Page 587]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 589_SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED--Table of 
 
 Subpart B_Listing of Specific Substances Prohibited From Use in Animal 
                              Food or Feed
 
Sec. 589.1000  Gentian violet.


    The Food and Drug Administration has determined that gentian violet 
has not been shown by adequate scientific data to be safe for use in 
animal feed. Use of gentian violet in animal feed causes the feed to be 
adulterated and in violation of the Federal Food, Drug, and Cosmetic Act 
(the act), in the absence of a regulation providing for its safe use as 
a food additive under section 409 of the act, unless it is subject to an 
effective notice of claimed investigational exemption for a food 
additive under Sec. 570.17 of this chapter, or unless the substance is 
intended for use as a new animal drug and is subject to an approved 
application under section 512 of the act, or an index listing under 
section 572 of the act, or an effective notice of claimed 
investigational exemption for a new animal drug under part 511 of this 
chapter or Sec. 516.125 of this chapter.

[72 FR 69131, Dec. 6, 2007]