0016 21cfr171

§ 170.105

21 CFR Ch. I (4–1–05 Edition)

the manufacturer or supplier on the
date the petition is received by FDA.

ISTER, FDA will no longer accept
NFCSFs.
(c) An NFCSF must contain the following:
(1) A completed and signed FDA
Form No. 3479; and
(2) Any additional documentation required to establish that each component of the formulation already may be
marketed legally for its intended use.

§ 170.105 The Food and Drug Administration’s (FDA’s) determination that
a premarket notification for a food
contact substance (FCN) is no
longer effective.
(a) If data or other information available to FDA, including data not submitted by the manufacturer or supplier, demonstrate that the intended
use of the food contact substance is no
longer safe, FDA may determine that
the authorizing FCN is no longer effective.
(b) If FDA determines that an FCN is
no longer effective, FDA will inform
the manufacturer or supplier in writing
of the basis for that determination.
FDA will give the manufacturer or supplier an opportunity to show why the
FCN should continue to be effective
and will specify the time that the manufacturer or supplier will have to respond.
(c) If the manufacturer or supplier
fails to respond adequately to the safety concerns regarding the notified use,
FDA will publish a notice of its determination that the FCN is no longer effective. FDA will publish this notice in
the FEDERAL REGISTER, stating that a
detailed summary of the basis for
FDA’s determination that the FCN is
no longer effective has been placed on
public display and that copies are
available upon request. The date that
the notice publishes in the FEDERAL
REGISTER is the date on which the notification is no longer effective.
(d) FDA’s determination that an FCN
is no longer effective is final agency
action subject to judicial review.

PART 171—FOOD ADDITIVE
PETITIONS
Subpart A—General Provisions
Sec.
171.1 Petitions.
171.6 Amendment of petition.
171.7 Withdrawal of petition without prejudice.
171.8 Threshold of regulation for substances
used in food-contact articles.

Subpart B—Administrative Actions on
Applications
171.100 Regulation based on petition.
171.102 Effective date of regulation.
171.110 Procedure for objections and hearings.
171.130 Procedure for amending and repealing tolerances or exemptions from tolerances.
AUTHORITY: 21 U.S.C. 321, 342, 348, 371.
SOURCE: 42 FR 14489, Mar. 15, 1977, unless
otherwise noted.

Subpart A—General Provisions
§ 171.1

Petitions.

(a) Petitions to be filed with the
Commissioner under the provisions of
section 409(b) of the Federal Food,
Drug, and Cosmetic Act (the act) shall
be submitted in triplicate (quadruplicate, if intended uses include use in
meat, meat food product, or poultry
product). If any part of the material
submitted is in a foreign language, it
shall be accompanied by an accurate
and complete English translation. The
petition shall state petitioner’s post office address to which published notices
or orders issued or objections filed pursuant to section 409 of the Act may be
sent.
(b) Pertinent information may be incorporated in, and will be considered as

§ 170.106 Notification for a food contact
substance
formulation
(NFCSF).
(a) In order for the Food and Drug
Administration (FDA) to accept an
NFCSF, any food additive that is a
component of the formulation must be
authorized for its intended use in that
NFCSF.
(b) FDA may publish a notice in the
FEDERAL REGISTER stating that the
agency has insufficient resources to review NFCSFs. From the date that this
notice publishes in the FEDERAL REG-

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Food and Drug Administration, HHS

§ 171.1
the characteristics of the substance or the
reliability of the controls may be specified.
If the food additive is a mixture of chemicals, the petition shall supply a list of all
substances used in the synthesis, extraction,
or other method of preparation, regardless of
whether they undergo chemical change in
the process. Each substance should be identified by its common English name and complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation is used
as a component, the proprietary name should
be followed by a complete quantitative
statement of composition. Reasonable alternatives for any listed substance may be specified.
If the petitioner does not himself perform
all the manufacturing, processing, and packing operations for a food additive, the petition shall identify each person who will perform a part of such operations and designate
the part.
The petition shall include stability data,
and, if the data indicate that it is needed to
insure the identity, strength, quality, or purity of the additive, the expiration date that
will be employed.
B. The amount of the food additive proposed for use and the purposes for which it is
proposed, together with all directions, recommendations, and suggestions regarding
the proposed use, as well as specimens of the
labeling proposed for the food additive and
any labeling that will be required by applicable provisions of the Federal Food, Drug, and
Cosmetic Act on the finished food by reason
of the use of the food additive. If the additive
results or may reasonably be expected to result from the use of packaging material, the
petitioner shall show how this may occur
and what residues may reasonably be anticipated.
(Typewritten or other draft-labeling copy
will be accepted for consideration of the petition, provided a statement is made that
final printed labeling identical in content to
the draft copy will be submitted as soon as
available and prior to the marketing of the
food additive.)
(If the food additive is one for which a tolerance limitation is required to assure its
safety, the level of use proposed should be no
higher than the amount reasonably required
to accomplish the intended physical or other
technical effect, even though the safety data
may support a higher tolerance.)
C. Data establishing that the food additive
will have the intended physical or other
technical effect or that it may reasonably be
expected to become a component, or to affect
the characteristics, directly or indirectly, of
food and the amount necessary to accomplish this. These data should include information in sufficient detail to permit evaluation with control data.

part of, a petition on the basis of specific reference to such information submitted to and retained in the files of
the Food and Drug Administration.
However, any reference to unpublished
information furnished by a person
other than the applicant will not be
considered unless use of such information is authorized in a written statement signed by the person who submitted it. Any reference to published
information offered in support of a food
additive petition should be accompanied by reprints or photostatic copies of such references.
(c) Petitions shall include the following data and be submitted in the
following form:
(Date)
Name of petitioner lllllllllllll
Post-office address lllllllllllll
Date lllllllllllllllllllll
Name of food additive and proposed use
ll
llllllllllllllllllllllll
Petitions Control Branch
Food and Drug Administration
Department of Health and Human Services
Washington, DC 20204.
DEAR SIRS:
The undersigned, lllll submits this
petition pursuant to section 409(b)(1) of the
Federal Food, Drug, and Cosmetic Act with
respect to lllll
(Name of the food additive and proposed use)
Attached hereto, in triplicate (quadruplicate, if intended uses include use in meat,
meat food product, or poultry product), and
constituting a part of this petition are the
following:
A. The name and all pertinent information
concerning the food additive, including
chemical identity and composition of the
food additive, its physical, chemical, and biological properties, and specifications prescribing the minimum content of the desired
component(s) and identifying and limiting
the reaction byproducts and other impurities. Where such information is not available, a statement as to the reasons why it is
not should be submitted.
When the chemical identity and composition of the food additive is not known, the
petition shall contain information in sufficient detail to permit evaluation regarding
the method of manufacture and the analytical controls used during the various stages
of manufacturing, processing, or packing of
the food additive which are relied upon to establish that it is a substance of reproducible
composition. Alternative methods and controls and variations in methods and controls
within reasonable limits that do not affect

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§ 171.1

21 CFR Ch. I (4–1–05 Edition)

D. A description of practicable methods to
determine the amount of the food additive in
the raw, processed, and/or finished food and
of any substance formed in or on such food
because of its use. The test proposed shall be
one that can be used for food-control purposes and that can be applied with consistent
results by any properly equipped and trained
laboratory personnel.
E. Full reports of investigations made with
respect to the safety of the food additive.
(A petition may be regarded as incomplete
unless it includes full reports of adequate
tests reasonably applicable to show whether
or not the food additive will be safe for its
intended use. The reports ordinarily should
include detailed data derived from appropriate animal and other biological experiments in which the methods used and the results obtained are clearly set forth. The petition shall not omit without explanation any
reports of investigations that would bias an
evaluation of the safety of the food additive.)
F. Proposed tolerances for the food additive, if tolerances are required in order to insure its safety. A petitioner may include a
proposed regulation.
G. If submitting petition to modify an existing regulation issued pursuant to section
409(c)(1)(A) of the Act, full information on
each proposed change that is to be made in
the original regulation must be submitted.
The petition may omit statements made in
the original petition concerning which no
change is proposed. A supplemental petition
must be submitted for any change beyond
the variations provided for in the original
petition and the regulation issued on the
basis of the original petition.
H. The petitioner is required to submit either a claim for categorical exclusion under
§ 25.30 or 25.32 of this chapter or an environmental assessment under § 25.40 of this chapter.

have already been submitted with an
earlier application, the present petition may incorporate it by specific reference to the earlier. If part of the data
have been submitted by the manufacturer of the food additive as a master
file, the petitioner may refer to the
master file if and to the extent he obtains the manufacturer’s written permission to do so. The manufacturer
may authorize specific reference to the
data without disclosure to the petitioner. Nothing herein shall prevent
reference to published data.
(g) A petition shall be retained but
shall not be filed if any of the data prescribed by section 409(b) of the Act are
lacking or are not set forth so as to be
readily understood.
(h)(1) The following data and information in a food additive petition are
available for public disclosure, unless
extraordinary
circumstances
are
shown, after the notice of filing of the
petition is published in the FEDERAL
REGISTER or, if the petition is not
promptly filed because of deficiencies
in it, after the petitioner is informed
that it will not be filed because of the
deficiencies involved:
(i) All safety and functionality data
and information submitted with or incorporated by reference in the petition.
(ii) A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets
and confidential commercial information in § 20.61 of this chapter.
(iii) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of:
(a) Names and any information that
would identify the person using the
product.
(b) Names and any information that
would identify any third party involved
with the report, such as a physician or
hospital or other institution.
(iv) A list of all ingredients contained
in a food additive, whether or not it is
in descending order of predominance. A
particular ingredient or group of ingredients shall be deleted from any such
list prior to public disclosure if it is
shown to fall within the exemption established in § 20.61 of this chapter, and
a notation shall be made that any such
ingredient list is incomplete.

Yours very truly,
Petitioner llllllllllllllllll
By llllllllllllllllllllll
(Indicate authority)

(d) The petitioner will be notified of
the date on which his petition is filed;
and an incomplete petition, or one that
has not been submitted in triplicate,
will usually be retained but not filed as
a petition under section 409 of the Act.
The petitioner will be notified in what
respects his petition is incomplete.
(e) The petition must be signed by
the petitioner or by his attorney or
agent, or (if a corporation) by an authorized official.
(f) The data specified under the several lettered headings should be submitted on separate sheets or sets of
sheets, suitably identified. If such data

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Food and Drug Administration, HHS

§ 171.1

(v) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is
shown to fall within the exemption established in § 20.61 of this chapter.
(2) The following data and information in a food additive petition are not
available for public disclosure unless
they have been previously disclosed to
the public as defined in § 20.81 of this
chapter or they relate to a product or
ingredient that has been abandoned
and they no longer represent a trade
secret or confidential commercial or financial information as defined in § 20.61
of this chapter:
(i) Manufacturing methods or processes, including quality control procedures.
(ii) Production, sales, distribution,
and similar data and information, except that any compilation of such data
and information aggregated and prepared in a way that does not reveal
data or information which is not available for public disclosure under this
provision is available for public disclosure.
(iii) Quantitative or semiquantitative formulas.
(3) All correspondence and written
summaries of oral discussions relating
to a food additive petition are available for public disclosure in accordance
with the provisions of part 20 of this
chapter when the food additive regulation is published in the FEDERAL REGISTER.
(4) For purposes of this regulation,
safety and functionality data include
all studies and tests of a food additive
on animals and humans and all studies
and tests on a food additive for identity, stability, purity, potency, performance, and usefulness.
(i)(1)(i) Within 15 days after receipt,
the Food and Drug Administration will
notify the petitioner of the acceptance
or nonacceptance of a petition, and if
not accepted, the reasons therefor. If
accepted, the petitioner will be sent a
letter stating this and the date of the
letter shall become the date of filing
for the purposes of section 409(b)(5) of
the act. In cases in which the Food and
Drug Administration agrees that a premarket notification for a food contact
substance (Food Contact Notification
(FCN)) submitted under section 409(h)

of the act may be converted to a petition, the withdrawal date for the FCN
will be deemed the date of receipt for
the petition.
(ii) If the petitioner desires, he may
supplement a deficient petition after
being notified regarding deficiencies. If
the supplementary material or explanation of the petition is deemed acceptable, the petitioner shall be notified. The date of such notification becomes the date of filing. If the petitioner does not wish to supplement or
explain the petition and requests in
writing that it be filed as submitted,
the petition shall be filed and the petitioner so notified.
(iii)
Notwithstanding
paragraph
(i)(1)(ii) of this section, the petition
shall not be filed if the Food and Drug
Administration determines that the
use identified in the petition should be
the subject of an FCN under section
409(h) of the act rather than a petition.
(2) The Commissioner will publish in
the FEDERAL REGISTER within 30 days
from the date of filing of such petition,
a notice of the filing, the name of the
petitioner, and a brief description of
the proposal in general terms. In the
case of a food additive which becomes a
component of food by migration from
packaging material, the notice shall
include the name of the migratory substance, and where it is different from
that of one of the original components,
the name of the parent component, the
maximum quantity of the migratory
substance that is proposed for use in
food, and the physical or other technical effect which the migratory substance or its parent component is intended to have in the packaging material. A copy of the notice will be
mailed to the petitioner when the
original is forwarded to the FEDERAL
REGISTER for publication.
(j) The Commissioner may request a
full description of the methods used in,
and the facilities and controls used for,
the production of the food additive, or
a sample of the food additive, articles
used as components thereof, or of the
food in which the additive is proposed
to be used, at any time while a petition
is under consideration. The Commissioner shall specify in the request for a
sample of the food additive, or articles
used as components thereof, or of the

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§ 171.6

21 CFR Ch. I (4–1–05 Edition)
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.
(2) 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.

food in or on which the additive is proposed to be used, a quantity deemed
adequate to permit tests of analytical
methods to determine quantities of the
food additive present in foods for which
it is intended to be used or adequate
for any study or investigation reasonably required with respect to the safety
of the food additive or the physical or
technical effect it produces. The date
used for computing the 90-day limit for
the purposes of section 409(c)(2) of the
Act shall be moved forward 1 day for
each day after the mailing date of the
request taken by the petitioner to submit the sample. If the information or
sample is requested a reasonable time
in advance of the 180 days, but is not
submitted within such 180 days after
filing of the petition, the petition will
be considered withdrawn without prejudice.
(k) If nonclinical laboratory studies
are involved, petitions filed with the
Commissioner under section 409(b) of
the act shall include, with respect to
each nonclinical study contained in the
petition, either a statement that the
study has been, or will be, conducted in
compliance with the good laboratory
practice regulations as set forth in part
58 of this chapter, or, if any such study
was not conducted in compliance with
such regulations, a brief statement of
the reason for the noncompliance.
(l) [Reserved]
(m) If clinical investigations involving human subjects are involved, petitions filed with the Commissioner
under section 409(b) of the Act shall include statements regarding each such
clinical investigation relied upon in
the petition that it either was conducted in compliance with the requirements for institutional review set forth
in part 56 of this chapter, or was not
subject to such requirements in accordance with § 56.104 or § 56.105, and that it
was conducted in compliance with the
requirements for informed consent set
forth in part 50 of this chapter.
(n)(1) If intended uses of the food additive 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 the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601 et

[42 FR 14489, Mar. 15, 1977, as amended at 42
FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27,
1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26,
1985; 62 FR 40599, July 29, 1997; 65 FR 51763,
Aug. 25, 2000; 67 FR 35731, May 21, 2002]
EFFECTIVE DATE NOTE: At 65 FR 51763, Aug.
25, 2000, § 171.1 was amended in paragraph (a)
by revising the first sentence, in paragraph
(c) in the petition by revising the introductory paragraph preceding paragraph A., and
by adding paragraph (n). The revised and
added text contains information collection
and recordkeeping requirements and will not
become effective until approval has been
given by the Office of Management and
Budget.

§ 171.6

Amendment of petition.

After a petition has been filed, the
petitioner may submit additional information or data in support thereof.
In such cases, if the Commissioner determines that the additional information or data amount to a substantive
amendment, the petition as amended
will be given a new filing date, and the
time limitation will begin to run anew.
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.
[50 FR 7492, Feb. 22, 1985, as amended at 50
16668, Apr. 26, 1985]

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