[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR80.31]
[Page 430]
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.
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