[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: 21CFR80.31]

[Page 427]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 80--COLOR ADDITIVE CERTIFICATION--Table of Contents
 
                   Subpart B--Certification Procedures
 
Sec. 80.31  Certification.

    (a) If the Commissioner determines, after such investigations as he 
considers to be necessary, that:
    (1) A request submitted in accordance with Sec. 80.21 appears to 
contain no untrue statement of a material fact;
    (2) Such color additive conforms to the specifications and any other 
conditions set forth therefor in parts 81 and 82 of this chapter.
    (3) The batch covered by such request otherwise appears to comply 
with the regulations in this chapter, the Commissioner shall issue to 
the person who submitted such request a certificate showing the lot 
number assigned to such batch and that such batch, subject to the terms, 
conditions, and restrictions prescribed by part 74, 81, and 82 of this 
chapter, is a certified batch.
    (b) If the Commissioner determines, after such investigation as he 
considers to be necessary, that a request submitted in accordance with 
Sec. 80.21, or the batch of color additive covered by such request, does 
not comply with the requirements prescribed by paragraph (a) of this 
section for the issuance of a certificate, the Commissioner shall refuse 
to certify such batch and shall give notice thereof to the person who 
submitted such request, stating his reasons for refusal. Any person who 
contests such refusal shall have an opportunity for a regulatory hearing 
before the Food and Drug Administration pursuant to part 16 of this 
chapter.