0016 21cfr70

§ 70.20

21 CFR Ch. I (4–1–05 Edition)

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
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]

Subpart B—Packaging and
Labeling
§ 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.

§ 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

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Food and Drug Administration, HHS

§ 70.50

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.

Subpart C—Safety Evaluation
§ 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.
§ 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 cer-

tain 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.
§ 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.
§ 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

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