[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.38]

[Page 16-17]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 170--FOOD ADDITIVES--Table of Contents
 
                     Subpart B--Food Additive Safety
 
Sec. 170.38  Determination of food additive status.

    (a) The Commissioner may, in accordance with Sec. 170.35(b)(4) or 
(c)(5), publish a notice in the Federal Register determining that a 
substance is not GRAS and is a food additive subject to section 409 of 
the Act.
    (b)(1) The Commissioner, on his own initiative or on the petition of 
any interested person, pursuant to part 10 of this chapter, may issue a 
notice in the Federal Register proposing to determine that a substance 
is not GRAS and

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is a food additive subject to section 409 of the Act. Any petition shall 
include all relevant data and information of the type described in 
Sec. 171.130(b). The Commissioner will place all of the data and 
information on which he relies on public file in the office of the 
Dockets Management Branch and will include in the Federal Register 
notice the name of the substance, its known uses, and a summary of the 
basis for the determination.
    (2) The Federal Register notice will allow a period of 60 days 
during which any interested person may review the data and information 
and/or file comments with the Dockets Management Branch. Copies of all 
comments shall be made available for examination in the Dockets 
Management Branch's office.
    (3) The Commissioner will evaluate all comments received. If he 
concludes that there is a lack of convincing evidence that the substance 
is GRAS or is otherwise exempt from the definition of a food additive in 
section 201(s) of the Act, he will publish a notice thereof in the 
Federal Register. If he concludes that there is convincing evidence that 
the substance is GRAS, he will publish an order in the Federal Register 
listing the substance as GRAS in part 182, part 184, or part 186 of this 
chapter, as appropriate.
    (c) A Federal Register notice determining that a substance is a food 
additive shall provide for the use of the additive in food or food 
contact surfaces as follows:
    (1) It may promulgate a food additive regulation governing use of 
the additive.
    (2) It may promulgate an interim food additive regulation governing 
use of the additive.
    (3) It may require discontinuation of the use of the additive.
    (4) It may adopt any combination of the above three approaches for 
different uses or levels of use of the additive.
    (d) If the Commissioner of Food and Drugs is aware of any prior 
sanction for use of the substance, he will concurrently propose a 
separate regulation covering such use of the ingredient under part 181 
of this chapter. If the Commissioner is unaware of any such applicable 
prior sanction, the proposed regulation will so state and will require 
any person who intends to assert or rely on such sanction to submit 
proof of its existence. Any regulation promulgated pursuant to this 
section constitutes a determination that excluded uses would result in 
adulteration of the food in violation of section 402 of the Act, and the 
failure of any person to come forward with proof of such an applicable 
prior sanction in response to the proposal will constitute a waiver of 
the right to assert or rely on such sanction at any later time. The 
notice will also constitute a proposal to establish a regulation under 
part 181 of this chapter, incorporating the same provisions, in the 
event that such a regulation is determined to be appropriate as a result 
of submission of proof of such an applicable prior sanction in response 
to the proposal.

[42 FR 14488, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 
54 FR 24896, June 12, 1989]