[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: 21CFR71.1]
[Page 331-334]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 71 COLOR ADDITIVE PETITIONS--Table of Contents
Subpart A General Provisions
Sec. 71.1 Petitions.
(a) Any interested person may propose the listing of a color
additive for use in or on any food, drug, or cosmetic or for coloring
the human body. Such proposal shall be made in a petition in the form
prescribed in paragraph (c) of this section. The petition shall be
submitted in triplicate (quadruplicate, if intended uses include uses 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 petitioner shall state
the post-office address in the United States to which published notices
or orders issued or objections filed pursuant to section 721 of the act
may be sent.
(b) Pertinent information may be incorporated in, and will be
considered as 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 However, any reference to unpublished information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 the information. Any reference to
published information offered in support of a color 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______________________________________________________
Post-office address_____________________________________________________
[[Page 332]]
Name of color additive and proposed use_________________________________
Office of Food Additive Safety (HFS-200),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5100 Paint Branch Pkwy.,
College Park, MD 20740
Dear Sir:
Petitioner submits this pursuant to section 721(b)(1) of the Federal
Food, Drug, and Cosmetic Act requesting listing by the Commissioner of
the color additive ---------- as suitable and safe for use in or on ----
------ subject to the conditions that --------------. [Petitioner may
propose a listing for general use in food, drugs, or cosmetics or, if
such general listing is not believed suitable and safe, the petitioner
shall describe the conditions under which he believes the additive can
be safely used and for which it will be suitable. These conditions may
include tolerance limitations, specifications as to the manner in which
the additive may be added or used, and directions and other labeling or
packaging safeguards that should be applied. The level of use proposed
should not be higher than reasonably required to accomplish the intended
color effect.]
Attached hereto, in triplicate (quadruplicate, if intended uses
include uses 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 color
additive, including chemical identity and composition of the color
additive, its physical, chemical, and biological properties, and
specifications prescribing its component(s) and identifying and limiting
the reaction byproducts and other impurities.
The petition shall contain a description of the chemical and
physical tests relied upon to identify the color additive and shall
contain a full description of the methods used in, and the facilities
and controls used for, the production of the color additive. These shall
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 the characteristics of the
substance or the reliability of the controls may be specified.
The petition shall supply a list of all substances used in the
synthesis, extraction, or other method of preparation of any straight
color, regardless of whether they undergo chemical change in the
process. Each substance should be identified by its common or usual name
and its 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
quantitive 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 color additive, the petitioner
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 color additive, the expiration period that will be employed as
well as any packaging and labeling precautions needed to preserve
stability.
B. The amount of the color additive proposed for use and the color
effect intended to be achieved, together with all directions,
recommendations, and suggestions regarding the proposed use, as well as
specimens of the labeling proposed for the color additive. If the color
effect results or may reasonably be expected to result from use of the
color additive in 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 final printed labeling identical
in content to the draft copy is submitted as soon as available, and
prior to the marketing of the color additive. The printed labeling shall
conform in prominence and conspicuousness with the requirements of the
act.
If the color 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. If the safety data will not support the use
of the amount of the color additive reasonably needed to accomplish the
desired color effect, the requested tolerance will not be established.
Petitioners are expected to propose the use of color additives in
accordance with sound color chemistry.
C.1. A description of practicable methods to determine the pure
color and all intermediates, subsidiary colors, and other components of
the color additive.
2. A description of practicable methods to determine the amount of
the color additive in any raw, processed, and/or finished food, drug, or
cosmetic in which use of the color additive is proposed. (The tests
proposed shall be those that can be used for food, drug, or cosmetic
control purposes and can be applied with consistent results by any
properly equipped laboratory and trained personnel.)
3. A description of methods for identification and determination of
any substance formed in or on such food, drug, or cosmetic because of
the use of the color additive. (If it
[[Page 333]]
is the petitioner's view that any such method would not be needed, under
the terms of section 721(b)(5)(A)(iv), a statement shall be submitted in
lieu of methods as to the basis for such view.)
D. Full reports of investigation made with respect to the safety of
the color additive.
(A petition will be regarded as incomplete unless it includes full
reports of adequate tests reasonably applicable to show whether or not
the color 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 data that would influence the evaluation of the
safety of the color additive).
E. Complete data which will allow the Commissioner to consider,
among other things, the probable consumption of, and/or other relevant
exposure from the additive and of any substance formed in or on food,
drugs, or cosmetics because of such additive; and the cumulative effect,
if any, of such additive in the diet of man or animals, taking into
account the same or any chemically or pharmacologically related
substance or substances in the diet including, but not limited to food
additives and pesticide chemicals for which tolerances or exemptions
from tolerances have been established.
F. Proposed tolerances and other limitations on the use of the color
additive, if tolerances and limitations are required in order to insure
its safety. A petitioner may include a proposed regulation.
G. If exemption from batch certification is requested, the reasons
why it is believed such certification is not necessary (including
supporting data to establish the safety of the intended use).
H. If submitting a petition to alter an existing regulation issued
pursuant to section 721(b) 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.
I. The prescribed fee of $------------ for admitting the color
additive to listing is enclosed (unless there is an advance deposit
adequate to cover the fee).
Yours very truly,
(Petitioner)____________________________________________________________
By -------------- (Indicate authority)
J. The petitioner is required to submit either 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.
(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 be retained but not filed. A petition
shall be retained but shall not be filed if any of the data listed in
the above form are lacking or are not set forth so as to be readily
understood or if the prescribed fee has not been submitted. 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 authorized agent, who is a resident of the United States.
(f) The data specified under the several lettered headings should be
submitted on separate sheets or sets of sheets, suitably identified. If
such data have already been submitted with an earlier application, the
present petition may incorporate it by specific reference to the earlier
petition.
(g) If nonclinical laboratory studies are involved, petitions filed
with the Commissioner under section 721(b) of the act shall include with
respect to each nonclinical study contained in the petition, either a
statement that the study was conducted in compliance with the good
laboratory practice regulations 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.
(h) [Reserved]
(i) If clinical investigations involving human subjects are
involved, petitions filed with the Commissioner under section 721(b) of
the act shall include statements regarding each such clinical
investigation contained 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 Sec. Sec. 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.
(j)(1) If intended uses of the color additive include uses in meat,
meat food product, or poultry product subject to
[[Page 334]]
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 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.
[42 FR 15639, Mar. 22, 1977, as amended at 43 FR 60021, Dec. 22, 1978;
46 FR 8952, Jan. 27, 1981; 50 FR 7491, Feb. 22, 1985; 50 FR 16668, Apr.
26, 1985; 54 FR 24890, June 12, 1989; 61 FR 14478, Apr. 2, 1996; 62 FR
40598, July 29, 1997; 65 FR 51762, Aug. 25, 2000; 66 FR 56035, Nov. 6,
2001]
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