This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70]
[Page 328-335]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES
Subpart A--General Provisions
Sec.
70.3 Definitions.
70.5 General restrictions on use of color additives.
70.10 Color additives in standardized foods and new drugs.
70.11 Related substances.
70.19 Fees for listing.
Subpart B--Packaging and Labeling
70.20 Packaging requirements for straight colors (other than hair
dyes).
70.25 Labeling requirements for color additives (other than hair dyes).
Subpart C--Safety Evaluation
70.40 Safety factors to be considered.
70.42 Criteria for evaluating the safety of color additives.
70.45 Allocation of color additives.
70.50 Application of the cancer clause of section 721 of the act.
70.51 Advisory committee on the application of the anticancer clause.
70.55 Request for scientific studies.
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 360b, 361, 371,
379e.
Source: 42 FR 15636, Mar. 22, 1977, unless otherwise noted.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.3]
[Page 328-330]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart A--General Provisions
Sec. 70.3 Definitions.
(a) Secretary means the Secretary of Health and Human Services.
(b) Department means the Department of Health and Human Services.
(c) Commissioner means the Commissioner of Food and Drugs.
(d) Act means the Federal Food, Drug, and Cosmetic Act as amended.
(e) Color Certification Branch means the unit established within the
Food and Drug Administration located in the Center for Food Safety and
Applied Nutrition, charged with the responsibility for the mechanics of
the certification procedure hereinafter described, and including the
examination of samples of color additives subject to certification.
(f) A color additive is any material, not exempted under section
201(t) of the act, that is a dye, pigment, or other substance made by a
process of synthesis or similar artifice, or extracted, isolated, or
otherwise derived, with or without intermediate or final change of
identity, from a vegetable, animal, mineral, or other source and that,
when added or applied to a food, drug, or cosmetic or to the human body
or any part thereof, is capable (alone or through reaction with another
substance) of imparting a color thereto. Substances capable of imparting
a color to a container for foods, drugs, or
[[Page 329]]
cosmetics are not color additives unless the customary or reasonably
foreseeable handling or use of the container may reasonably be expected
to result in the transmittal of the color to the contents of the package
or any part thereof. Food ingredients such as cherries, green or red
peppers, chocolate, and orange juice which contribute their own natural
color when mixed with other foods are not regarded as color additives;
but where a food substance such as beet juice is deliberately used as a
color, as in pink lemonade, it is a color additive. Food ingredients as
authorized by a definitions and standard of identity prescribed by
regulations pursuant to section 401 of the act are color additives,
where the ingredients are specifically designated in the definitions and
standards of identity as permitted for use for coloring purposes. An
ingredient of an animal feed whose intended function is to impart,
through the biological processes of the animal, a color to the meat,
milk, or eggs of the animal is a color additive and is not exempt from
the requirements of the statute. This definition shall apply whether or
not such ingredient has nutritive or other functions in addition to the
property of imparting color. An ingested drug the intended function of
which is to impart color to the human body is a color additive. For the
purposes of this part, the term color includes black, white, and
intermediate grays, but substances including migrants from packaging
materials which do not contribute any color apparent to the naked eye
are not color additives.
(g) For a material otherwise meeting the definition of color
additive to be exempt from section 721 of the act, on the basis that it
is used (or intended to be used) solely for a purpose or purposes other
than coloring, the material must be used in a way that any color
imparted is clearly unimportant insofar as the appearance, value,
marketability, or consumer acceptability is concerned. (It is not enough
to warrant exemption if conditions are such that the primary purpose of
the material is other than to impart color.)
(h) The exemption that applies to a pesticide chemical, soil or
plant nutrient, or other agricultural chemical, where its coloring
effect results solely from its aiding, retarding, or otherwise affecting
directly or indirectly, the growth or other natural physiological
processes of produce of the soil, applies only to color developed in
such product through natural physiological processes such as enzymatic
action. If the pesticide chemical, soil or plant nutrient, or other
agricultural chemical itself acts as a color or carries as an ingredient
a color, and because of this property colors the produce of the soil, it
is a color additive and is not exempt.
(i) Safe means that there is convincing evidence that establishes
with reasonable certainty that no harm will result from the intended use
of the color additive.
(j) The term straight color means a color additive listed in parts
73, 74, and 81 of this chapter, and includes lakes and such substances
as are permitted by the specifications for such color.
(k) The term mixture means a color additive made by mixing two or
more straight colors, or one or more straight colors and one or more
diluents.
(l) The term lake means a straight color extended on a substratum by
adsorption, coprecipitation, or chemical combination that does not
include any combination of ingredients made by simple mixing process.
(m) The term diluent means any component of a color additive mixture
that is not of itself a color additive and has been intentionally mixed
therein to facilitate the use of the mixture in coloring foods, drugs,
or cosmetics or in coloring the human body. The diluent may serve
another functional purpose in the foods, drugs, or cosmetics, as for
example sweetening, flavoring, emulsifying, or stabilizing, or may be a
functional component of an article intended for coloring the human body.
(n) The term substratum means the substance on which the pure color
in a lake is extended.
(o) The term pure color means the color contained in a color
additive, exclusive of any intermediate or other component, or of any
diluent or substratum contained therein.
(p) The term batch means a homogeneous lot of color additive or
color additive mixture produced by an identified production operation,
which is
[[Page 330]]
set apart and held as a unit for the purpose of obtaining certification
of such quantity.
(q) The term batch number means the number assigned to a batch by
the person who requests certification thereof.
(r) The term lot number means an identifying number or symbol
assigned to a batch by the Food and Drug Administration.
(s) The term area of the eye means the area enclosed with in the
circumference of the supra-orbital ridge and the infra-orbital ridge,
including the eyebrow, the skin below the eyebrow, the eyelids and the
eyelashes, and conjunctival sac of the eye, the eyeball, and the soft
areolar tissue that lies within the perimeter of the infra-orbital
ridge.
(t) The term package means the immediate container in which a color
additive or color additive mixture has been packed for shipment or
delivery. If the package is then packed in a shipping carton or other
protective container, such container shall not be considered to be the
immediate container. In the case of color additive mixtures for
household use containing less than 15 percent pure color, when two or
more containers of 3 ounces each or less, each containing a different
color, are distributed as a unit, the immediate container for such unit
shall be considered to be the package as defined in this section.
(u) The hair dye exemption in section 601(a) of the act applies to
coal tar hair dyes intended for use in altering the color of the hair
and which are, or which bear or contain, color additives derived from
coal tar with the sensitization potential of causing skin irritation in
certain individuals and possible blindness when used for dyeing the
eyelashes or eyebrows. The exemption is permitted with the condition
that the label of any such article bear conspicuously the statutory
caution and adequate directions for preliminary patch-testing. The
exemption does not apply to coloring ingredients in hair dyes not
derived from coal tar, and it does not extend to poisonous or
deleterious diluents that may be introduced as wetting agents, hair
conditions, emulsifiers, or other components in a color shampoo, rinse,
tint, or similar dual-purpose cosmetic that alter the color of the hair.
(v) The terms externally applied drugs and externally applied
cosmetics mean drugs or cosmetics applied only to external parts of the
body and not to the lips or any body surface covered by mucous membrane.
[42 FR 15636, Mar. 22, 1977, as amended at 61 FR 14478, Apr. 2, 1996]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.5]
[Page 330-331]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart A--General Provisions
Sec. 70.5 General restrictions on use of color additives.
(a) Color additives for use in the area of the eye. No listing or
certification of a color additive shall be considered to authorize the
use of any such color additive in any article intended for use in the
area of the eye unless such listing or certification of such color
additive specifically provides for such use. Any color additive used in
or on any article intended for use in the area of the eye, the listing
or certification of which color additive does not provide for such use,
shall be considered to be a color additive not listed under parts 73,
74, and 81 of this chapter, even though such color additive is certified
and/or listed for other uses.
(b) Color additives for use in injections. No listing or
certification of a color additive shall be considered to authorize the
use of any such color additive in any article intended for use in
injections unless such listing or certification of such color additive
specifically provides for such use. Any color additive used in or on any
article intended for use in injections, the listing or certification of
which color additive does not provide for such use, shall be considered
to be a color additive not listed under parts 73, 74, and 81 of this
chapter, even though such color additive is certified and/or listed for
other uses.
(c) Color additives for use in surgical sutures. No listing or
certification of a color additive shall be considered to authorize the
use of any such color additive in any article intended for use as a
surgical suture unless such listing or certification of such color
additive specifically provides for such use. Any color additive used in
or on any article intended for use as a surgical suture, the listing or
certification of which color additive does not provide for such
[[Page 331]]
use, shall be considered to be a color additive not listed under parts
73, 74, and 81 of this chapter, even though such color additive is
certified and/or listed for other uses.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.10]
[Page 331]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart A--General Provisions
Sec. 70.10 Color additives in standardized foods and new drugs.
(a) Standardized foods. (1) Where a petition is received for
issuance or amendment of a regulation establishing a definition and
standard of identity for a food under section 401 of the act, which
proposes the inclusion of a color additive in the standardized food, the
provisions of the regulations in part 71 of this chapter shall apply
with respect to the information that must be submitted with respect to
the safety of the color additive (if such information has not previously
been submitted and safety of the color additive for the intended use has
not been already established), and the petition must show also that the
use of the color additive in the standardized food would be in
conformance with section 401 of the act or with the terms of a temporary
permit issued under Sec. 130.17 of this chapter.
(2) If a petition for a definition and standard of identity contains
a proposal for a color additive regulation, and the petitioner fails to
designate it as such, the Commissioner, upon determining that the
petition includes a proposal for a color additive regulation, shall so
notify the petitioner and shall thereafter proceed in accordance with
the regulations in part 71 of this chapter.
(3) A regulation will not be issued allowing the use of a color
additive in a food for which a definition and standard of identity is
established, unless its issuance is in conformance with section 401 of
the act or with the terms of a temporary permit issued under Sec. 130.17
of this chapter. When the contemplated use of such additive complies
with the terms of a temporary permit, the color additive regulation will
be conditioned on such compliance and will expire with the expiration of
the temporary permit.
(b) New drugs. (1) Where an application for a new drug is received
and this application proposes, for coloring purposes only, the inclusion
of a color additive, the provisions of the regulations in part 71 of
this chapter shall apply with respect to the information that must be
submitted about the safety of the color additive, if such information
has not previously been submitted and safety of the color additive for
the intended use has not already been established.
(2) If an application for a new drug inferentially contains a
proposal for a color additive regulation, and the applicant fails to
designate it as such, the Commissioner, upon determining that the
application includes a proposal for a color additive regulation, shall
so notify the applicant and shall thereafter proceed in accordance with
the regulations in part 71 of this chapter.
(3) Where a petition for a color additive must be filed in
accordance with paragraph (b)(2) of this section, the date of filing of
the color additive petition shall be considered as the date of filing of
the new-drug application.
[42 FR 15636, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.11]
[Page 331]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart A--General Provisions
Sec. 70.11 Related substances.
(a) Different color additives may cause similar or related
pharmacological or biological effects, and, in the absence of evidence
to the contrary, those that do so will be considered to have additive
toxic effects.
(b) Food additives may also cause pharmacological or biological
effects similar or related to such effects caused by color additives,
and, in the absence of evidence to the contrary, those that do so will
be considered as having additive toxic effects.
(c) Pesticide chemicals may also cause pharmacological or biological
effects similar or related to such effects caused by color additives,
and, in the absence of evidence to the contrary, those that do so will
be considered to have additive toxic effects.
(d) In establishing tolerances for color additives, the Commissioner
will take into consideration, among other things, the amount of any
common component permitted in other color additives, in food additives,
and in pesticide chemical residues as well as the similar biological
activity (such as cholinesterase inhibition) produced by such substance.
[[Page 332]]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.19]
[Page 332-333]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart A--General Provisions
Sec. 70.19 Fees for listing.
(a) Each petition for the listing of a color additive shall be
accompanied by a deposit of $3,000.00 if the proposal is for listing the
color additive for use generally in or on foods, in or on drugs, and in
or on cosmetics.
(b) If the petition for the listing is for use in or on foods only,
the deposit shall be $3,000.00.
(c) If the petition for the listing is for use in or on drugs and/or
cosmetics only, the deposit shall be $2,600.00.
(d) The provisions of paragraphs (a), (b), and (c) of this section
shall be applicable, whether or not the proposal contemplates any
tolerances, limitations, or other restrictions placed upon the use of
the color additive.
(e) If a petition proposing the issuance of a regulation is
withdrawn before it is finally accepted for filing, the deposit, less a
$600.00 fee for clerical handling and administrative and technical
review, shall be returned to the petitioner.
(f) If a petition proposing the issuance of a regulation is
withdrawn within 30 days after filing, the deposit, less $1,800.00 if
the petition is covered by paragraph (a) or (b) of this section, and
less $1,600.00, if the petition is covered by paragraph (c) of this
section, shall be returned to the petitioner.
(g) When a petition is withdrawn after filing and resubmitted within
6 months, it shall be accompanied by a deposit of $1,800.00 for a
petition filed under paragraph (a) or (b) of this section, and $1,600.00
for a petition filed under paragraph (c) of this section. If a petition
is resubmitted after 6 months, it shall be accompanied by the deposit
that would be required if it were being submitted for the first time.
(h) When the resubmission pertains to a petition that had been
withdrawn before acceptance for filing, a new advance deposit shall be
made in full as prescribed in paragraph (a), (b), or (c) of this
section.
(i) After a color additive has been listed, any request for an
amendment or additional tolerance shall be accompanied by a deposit of
$1,800.00 for use in the items specified in paragraphs (a) and (b) of
this section, or $1,600.00 for use in items specified in paragraph (c)
of this section.
(j) The fee for services in listing a diluent under Sec. 80.35 for
use in color additive mixtures shall be $250.00.
(k) Objections and request for public hearing under section 721(d)
of the act or section 203(d)(2)(C) of Pub. L. 86-618 (74 Stat. 404; 21
U.S.C. 379e, note) shall be accompanied by a filing fee of $250.00.
(l) In the event of a referral of a petition under this section to
an advisory committee, all costs related thereto (including personal
compensation of committee members, travel materials, and other costs)
shall be borne by the person or organization requesting the referral,
such costs to be assessed on the basis of actual cost to the Government:
Provided, That the compensation of such costs shall include personal
compensation of advisory committee members at a rate not to exceed
$75.00 per member per day.
(m) In the case of requests of referrals to advisory committees, a
special advance deposit shall be made in the amount of $2,500.00. Where
required, further advance in increments of $2,500.00 each shall be made
upon request of the Commissioner of Food and Drugs. All deposits for
referrals to advisory committees in excess of actual expenses shall be
refunded to the depositor.
(n) All requests for pharmacological or other scientific studies
shall be accompanied by an advance deposit of $5,000.00. Further advance
deposits shall be made upon request of the Commissioner of Food and
Drugs when necessary to prevent arrears in such cost. Any deposits in
excess of actual expenses will be refunded to the depositor. If a
request is denied the advance deposit will be refunded less such costs
as are incurred for review of the request.
(o) The person who files a petition for judicial review of an order
under section 721(d) of the act shall pay the costs of preparing a
transcript of the record on which the order is based.
(p) All deposits and fees required by the regulations in this
section shall be paid by money order, bank draft or certified check
drawn to the order of the Food and Drug Administration, collectable at
par at Washington, DC All deposits and fees shall be forwarded to
[[Page 333]]
the Center for Food Safety and Applied Nutrition (HFS-200), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,
whereupon after making appropriate record thereof they will be
transmitted to the Treasurer of the United States for deposit in the
special account "Salaries and Expenses, Certification, Inspection, and
Other Services, Food and Drug Administration."
(q) The Commissioner of Food and Drugs may waive or refund such fees
in whole or in part when in his judgment such action will promote the
public interest.
(r) Any person who believes that payment of these fees will work a
hardship on him may petition the Commissioner of Food and Drugs to waive
or refund the fees.
[42 FR 15636, Mar. 22, 1977, as amended at 54 FR 24890, June 12, 1989;
61 FR 14478, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.20]
[Page 333]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart B--Packaging and Labeling
Sec. 70.20 Packaging requirements for straight colors (other than hair dyes).
Straight colors shall be packaged in containers which prevent
changes in composition. Packages shall be sealed so that they cannot be
opened without breaking the seal. An unavoidable change in moisture
content caused by the ordinary and customary exposure that occurs in
good storage, packing, and distribution practice is not considered a
change in composition. If the packaging material is a food additive it
shall be authorized by an appropriate regulation in parts 170 through
189 of this chapter.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.25]
[Page 333]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart B--Packaging and Labeling
Sec. 70.25 Labeling requirements for color additives (other than hair dyes).
(a) General labeling requirements. All color additives shall be
labeled with sufficient information to assure their safe use and to
allow a determination of compliance with any limitations imposed by this
part and parts 71, 73, 74, 80, and 81 of this chapter. In addition to
all other information required by the act, labels for color additives,
except those in a form suitable for coloring the human body, shall
state:
(1) The name of the straight color or the name of each ingredient
comprising the color additive, if it is a mixture.
(2) A statement indicating general limitations for the use of the
color additive, such as "for food use only"; "for food, drug, and
cosmetic use"; "for use in drugs for external application only."
(3) Where regulations issued impose quantitative limitations for a
general or specific use of a straight color, the amount of each such
straight color in terms of weight per unit/volume or percent by weight.
(4) An expiration date if stability data require it.
(b) Special labeling for color additives with tolerances. Where
tolerances are imposed for a general or specific use of a color
additive, the label shall in addition provide directions for use of the
color additive which if followed will preclude the food, drug, or
cosmetic to which it is added from containing an amount of the color
additive in excess of the tolerance.
(c) Special labeling for color additives with other limitations. If
use of the color additive is subject to other limitations prescribed in
this part, such limitations shall be stated on the label of the color
additive by a plain and conspicuous statement. Examples of such
limitation statements are: "Do not use in products used in the area of
the eye"; "Do not use for coloring drugs for injection."
(d) Special labeling for color additives not exempt from
certification. Color additives not exempt from the certification
procedures shall in addition include in the labeling the lot number
assigned by the Color Certification Branch, except that in the case of
any mixture for household use which contains not more than 15 percent of
pure color and which is in packages containing not more than 3 ounces
there appears on the label, a code number which the manufacturer has
identified with the lot number by giving to the Food and Drug
Administration written notice that such code number will be used in lieu
of the lot number.
[[Page 334]]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.40]
[Page 334]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart C--Safety Evaluation
Sec. 70.40 Safety factors to be considered.
In accordance with section 721(b)(5)(A)(iii) of the act, the
following safety factor will be applied in determining whether the
proposed use of a color additive will be safe: Except where evidence is
submitted which justifies use of a different safety factor, a safety
factor of 100 to 1 will be used in applying animal experimentation data
to man; that is, a color additive for use by man will not be granted a
tolerance that will exceed 1/100th of the maximum no-effect level for
the most susceptible experimental animals tested. The various species of
experimental animals used in the tests shall conform to good
pharmacological practice.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.42]
[Page 334]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart C--Safety Evaluation
Sec. 70.42 Criteria for evaluating the safety of color additives.
(a) In deciding whether a petition is complete and suitable for
filing and in reaching a decision on any petition filed, the
Commissioner will apply the "safe-for-use" principle. This will
require the presentation of all needed scientific data in support of a
proposed listing to assure that each listed color additive will be safe
for its intended use or uses in or on food, drugs, or cosmetics. The
Commissioner may list a color additive for use generally in or on food,
in or on drugs, or in or on cosmetics when he finds from the data
presented that such additive is suitable and may safely be employed for
such general use; he may list an additive only for more limited use or
uses for which it is proven suitable and may safely be employed; and he
is authorized to prescribe broadly the conditions under which the
additive may be safely employed for such use or uses. This may allow the
use of a particular dye, pigment, or other substance with certain
diluents, but not with others, or at a higher concentration with some
than with others.
(b) The safety for external color additives will normally be
determined by tests for acute oral toxicity, primary irritation,
sensitization, subacute dermal toxicity on intact and abraded skin, and
carcinogenicity by skin application. The Commissioner may waive any of
such tests if data before him otherwise establish that such test is not
required to determine safety for the use proposed.
(c) Upon written request describing the proposed use of a color
additive and the proposed experiments to determine its safety, the
Commissioner will advise a person who wishes to establish the safety of
a color additive whether he believes the experiments planned will yield
data adequate for an evaluation of the safety of the additive.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.45]
[Page 334]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart C--Safety Evaluation
Sec. 70.45 Allocation of color additives.
Whenever, in the consideration of a petition or a proposal to list a
color additive or to alter an existing listing, the data before the
Commissioner fail to show that it would be safe to list the color
additive for all the uses proposed or at the levels proposed, the
Commissioner will notify the petitioner and other interested persons by
publication in the Federal Register that it is necessary to allocate the
safe tolerance for the straight color in the color additive among the
competing needs. This notice shall call for the presentation of data by
all interested persons on which the allocation can be made in accordance
with section 721(b)(8) of the act. The time for acting upon the petition
shall be stayed until such data are presented, whereupon the time limits
shall begin to run anew. As promptly as possible after presentation of
the data, the Commissioner will, by order, announce the allocation and
the tolerance limitations.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.50]
[Page 334-335]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart C--Safety Evaluation
Sec. 70.50 Application of the cancer clause of section 721 of the act.
(a) Color additives that may be ingested. Whenever (1) the
scientific data before the Commissioner (either the reports from the
scientific literature or the results of biological testing) suggest the
possibility that the color additive including its components or
impurities has induced cancer when ingested by man or animal; or (2)
tests which are appropriate for the evaluation of the safety of
additives in food suggest that the color additive, including its
components or impurities, induces cancer in man or animal, the
Commissioner shall determine whether, based on the judgment of
appropriately qualified scientists, cancer has been induced and
[[Page 335]]
whether the color additive, including its components or impurities, was
the causative substance. If it is his judgment that the data do not
establish these facts, the cancer clause is not applicable; and if the
data considered as a whole establish that the color additive will be
safe under the conditions that can be specified in the applicable
regulation, it may be listed for such use. But if in the judgment of the
Commissioner, based on information from qualified scientists, cancer has
been induced, no regulation may issue which permits its use.
(b) Color additives that will not be ingested. Whenever the
scientific data before the Commissioner suggest the possibility that the
color additive, including its components or impurities, has induced
cancer in man or animals by routes other than ingestion, the
Commissioner shall determine whether, based on the judgment of
appropriately qualified scientists, the test suggesting the possibility
of carcinogenesis is appropriate for the evaluation of the color
additive for a use which does not involve ingestion, cancer has been
induced, and the color additive, including its components or impurities,
was the causative substance. If it is his judgment that the data do not
establish these facts, the cancer clause is not applicable to preclude
external drug and cosmetic uses, and if the data as a whole establish
that the color additive will be safe under conditions that can be
specified in the regulations, it may be listed for such use. But if, in
the judgment of the Commissioner, based on information from qualified
scientists, the test is an appropriate one for the consideration of
safety for the proposed external use, and cancer has been induced by the
color additive, including its components or impurities, no regulation
may issue which permits its use in external drugs and cosmetics.
(c) Color additives for use as an ingredient of feed for animals
that are raised for food production. Color additives that are an
ingredient of the feed for animals raised for food production and that
have the potential to contaminate human food with residues whose
consumption could present a risk of cancer to people must satisfy the
requirements of subpart E of part 500 of this chapter.
[42 FR 15636, Mar. 22, 1977, as amended at 43 FR 22675, May 26, 1978; 52
FR 49586, Dec. 31, 1987]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.51]
[Page 335]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart C--Safety Evaluation
Sec. 70.51 Advisory committee on the applicability of the anticancer clause.
All requests for and procedures governing any advisory committee on
the anticancer clause shall be subject to the provisions of part 14 of
this chapter, and particularly subpart H of that part.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.55]
[Page 335]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70--COLOR ADDITIVES--Table of Contents
Subpart C--Safety Evaluation
Sec. 70.55 Request for scientific studies.
The Commissioner will consider requests by any interested person who
desires the Food and Drug Administration to conduct scientific studies
to support a petition for a regulation for a color additive. If
favorably acted upon, such studies will be limited to pharmacological
investigations, studies of the chemical and physical structure of the
color additive, and methods of analysis of the pure color additive
(including impurities) and its identification and determination in
foods, drugs, or cosmetics, as the case may be. All requests for such
studies shall be accompanied by the fee prescribed in Sec. 70.19.
