[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR570.35]

[Page 490-491]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 570--FOOD ADDITIVES--Table of Contents
 
                     Subpart B--Food Additive Safety
 
Sec.  570.35  Affirmation of generally recognized as safe (GRAS) status.

    (a) The Commissioner, either on his initiative or on the petition of 
an interested person, may affirm the GRAS status of substances that 
directly or indirectly become components of food.
    (b)(1) If the Commissioner proposes on his own initiative that a 
substance is entitled to affirmation as GRAS, he 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 publish in the Federal Register a 
notice giving the name of the substance, its proposed uses, and any 
limitations proposed for purposes other than safety.
    (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 received 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 convincing evidence that the substance is GRAS 
as defined in Sec.  570.3(k), he will publish a notice in the Federal 
Register listing the substance in this subchapter E as GRAS.
    (4) If, after evaluation of the comments, the Commissioner concludes 
that there is a lack of convincing evidence that the substance is GRAS 
and that it should be considered a food additive subject to section 409 
of the act, he shall publish a notice thereof in the Federal Register in 
accordance with Sec.  570.38.
    (c)(1) Persons seeking the affirmation of GRAS status of substances 
as provided for in Sec.  570.30(e), except those subject to the NAS-NRC 
GRAS list survey (36 FR 20546), shall submit a petition for GRAS 
affirmation pursuant to part 10 of this chapter. Such petition shall 
contain information to establish that the GRAS criteria as set forth in 
Sec.  570.30(b) have been met, in the following form:
    (i) Description of the substance, including:
    (a) Common or usual name.
    (b) Chemical name.
    (c) Chemical Abstract Service (CAS) registry number.
    (d) Empirical formula.
    (e) Structural formula.
    (f) Specifications for food grade material, including arsenic and 
heavy metals. (Recommendation for any change in the Food Chemicals Codex 
monograph should be included where applicable.)
    (g) Quantitative compositions.
    (h) Manufacturing process (excluding any trade secrets).
    (ii) Use of the substance, including:
    (a) Date when use began.
    (b) Information and reports or other data on past uses in food.
    (c) Foods in which used, and levels of use in such foods, and for 
what purposes.
    (iii) Methods for detecting the substance in food, including:
    (a) References to qualitative and quantitative methods for 
determining the substance(s) in food, including the type of analytical 
procedures used.
    (b) Sensitivity and reproducibility of such method(s).
    (iv) Information to establish the safety and functionality of the 
substance in food. Published scientific literature,

[[Page 491]]

evidence that the substance is identical to a GRAS counterpart of 
natural biological origin, and other data may be submitted to support 
safety. Any adverse information or consumer complaints shall be 
included. Complete bibliographic references shall be provided where a 
copy of the article is not provided.
    (v) A statement signed by the person responsible for the petition 
that to the best of his knowledge it is a representative and balanced 
submission that includes unfavorable information, as well as favorable 
information, known to him pertinent to the evaluation of the safety and 
functionality of the substance.
    (vi) If nonclinical laboratory studies are involved, additional 
information and data submitted in support of filed petitions shall 
include, with respect to each nonclinical study, either a statement that 
the study was conducted in compliance with the requirements set forth in 
part 58 of this chapter, or, if the study was not conducted in 
compliance with such regulations, a brief statement of the reason for 
the noncompliance.
    (vii) [Reserved]
    (viii) A claim for categorical exclusion under Sec.  25.30 or 25.32 
of this chapter or an environmental assessment under Sec.  25.40 of this 
chapter.
    (2) Within 30 days after the date of filing the petition, the 
Commissioner will place the petition on public file in the Dockets 
Management Branch and will publish a notice of filing in the Federal 
Register giving the name of the petitioner and a brief description of 
the petition including the name of the substance, its proposed use, and 
any limitations proposed for reasons other than safety. A copy of the 
notice will be mailed to the petitioner at the time the original is sent 
to the Federal Register.
    (3) The notice of filing in the Federal Register will allow a period 
of 60 days during which any interested person may review the petition 
and/or file comments with the Dockets Management Branch. Copies of all 
comments received shall be made available for examination in the Dockets 
Management Branch.
    (4) The Commissioner will evaluate the petition and all available 
information including all comments received. If the petition and such 
information provide convincing evidence that the substance is GRAS as 
defined in Sec.  570.3, he will publish an order in the Federal Register 
listing the substance in this subchapter E as GRAS.
    (5) If, after evaluation of the petition and all available 
information, the Commissioner concludes that there is a lack of 
convincing evidence that the substance is GRAS and that it should be 
considered a food additive subject to section 409 of the act, he shall 
publish a notice thereof in the Federal Register in accordance with 
Sec.  570.38.
    (6) The notice of filing in the Federal Register will request 
submission of proof of any applicable prior sanction for use of the 
ingredient under conditions different from those proposed to be 
determined to be GRAS. The failure of any person to come forward with 
proof of such an applicable prior sanction in response to the notice of 
filing will constitute a waiver of the right to assert or rely on such 
sanction at any later time. The notice of filing will also constitute a 
proposal to establish a regulation under this subchapter E, 
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 notice of filing.

[41 FR 38644, Sept. 10, 1976, as amended at 42 FR 4717, Jan. 25, 1977; 
42 FR 15675, Mar. 22, 1977; 42 FR 55207, Oct. 10, 1977; 50 FR 7517, Feb. 
22, 1985; 50 FR 16668, Apr. 26, 1985; 54 FR 18281, Apr. 28, 1989; 62 FR 
40600, July 29, 1997]