0016 21cfr170

Food and Drug Administration, HHS

§ 170.35

achieve its intended purpose in that article.
(i) If a substance is affirmed as GRAS
in part 184 or § 186.1 of this chapter with
no limitation other than good manufacturing practice, it shall be regarded
as GRAS if its conditions of use are not
significantly different from those reported in the regulation as the basis on
which the GRAS status of the substance was affirmed. If the conditions
of use are significantly different, such
use of the substance may not be GRAS.
In such a case a manufacturer may not
rely on the regulation as authorizing
the use but must independently establish that the use is GRAS or must use
the substance in accordance with a
food additive regulation.
(j) If an ingredient is affirmed as
GRAS in part 184 or § 186.1 of this chapter with specific limitation(s), it may
be used in food only within such limitation(s) (including the category of
food(s), the functional use(s) of the ingredient, and the level(s) of use). Any
use of such an ingredient not in full
compliance with each such established
limitation shall require a food additive
regulation.
(k) Pursuant to § 170.35, a food ingredient may be affirmed as GRAS in part
184 or § 186.1 of this chapter for a specific use(s) without a general evaluation of use of the ingredient. In addition to the use(s) specified in the regulation, other uses of such an ingredient
may also be GRAS. Any affirmation of
GRAS status for a specific use(s), without a general evaluation of use of the
ingredient, is subject to reconsideration upon such evaluation.
(l) New information may at any time
require reconsideration of the GRAS
status of a food ingredient. Any change
in part 182, part 184, or § 186.1 of this
chapter shall be accomplished pursuant
to § 170.38.

(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 Division of Dockets
Management 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 Division of Dockets
Management. Copies of all comments
received shall be made available for examination in the Division of Dockets
Management’s office.
(3) The Commissioner will evaluate
all comments received. If he concludes
that there is convincing evidence that
the substance is GRAS as described in
§ 170.30, he will publish a notice in the
FEDERAL REGISTER listing the substance as GRAS in part 182, part 184, or
part 186 of this chapter, as appropriate.
(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
§ 170.38.
(c)(1) Persons seeking the affirmation
of GRAS status of substances as provided in § 170.30(e), except those subject
to the NAS/NRC GRAS list survey (36
FR 20546; October 23, 1971), 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 § 170.30 (b) or (c) 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

[42 FR 14483, Mar. 15, 1977, as amended at 49
FR 5610, Feb. 14, 1984; 53 FR 16546, May 10,
1988]

§ 170.35 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.

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§ 170.35

21 CFR Ch. I (4–1–05 Edition)

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,
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 § 25.30 or § 25.32 of this chapter or an environmental assessment
under § 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 office of the Division of Dockets
Management 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)(i) If intended uses of the substance include uses in meat, meat food
product, or poultry product subject to
regulation by the U.S. Department of
Agriculture (USDA) under the Poultry
Products Inspection Act (PPIA) (21
U.S.C. 451 et seq.) or Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et
seq.), FDA shall, upon filing of the petition, forward a copy of the petition or
relevant portions thereof to the Food
Safety and Inspection Service, USDA,
for simultaneous review under the
PPIA and FMIA.
(ii) FDA will ask USDA to advise
whether the proposed meat and poultry
uses comply with the FMIA and PPIA
or, if not, whether use of the substance
would be permitted in products under
USDA jurisdiction under specified conditions or restrictions.
(4) 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 Division of Dockets
Management. Copies of all comments
received shall be made available for examination in the Division of Dockets
Management’s office.
(5) 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 described in
§ 170.30 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.
(6) 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

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Food and Drug Administration, HHS

§ 170.38

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 § 170.38.
(7) 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 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 notice of filing.

(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 Division of Dockets
Management. Copies of all comments
shall be made available for examination in the Division of Dockets Management’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

(Information collection requirements were
approved by the Office of Management and
Budget under control number 0910–0132)
[42 FR 14488, Mar. 15, 1977, as amended at 50
FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26,
1985; 53 FR 16547, May 10, 1988; 62 FR 40599,
July 29, 1997; 65 FR 51762, Aug. 25, 2000]

§ 170.38 Determination of food additive status.
(a) The Commissioner may, in accordance with § 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
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 § 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 Division
of Dockets Management 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.

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