[Federal Register Volume 59, Number 32 (Wednesday, February 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3554]
[[Page Unknown]]
[Federal Register: February 16, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 74
[Docket No. 92C-0295]
Listing of Color Additives Subject to Certification; FD&C Blue
No. 1
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the color
additive regulations to provide for the safe use of FD&C Blue No. 1 and
FD&C Blue No. 1 Aluminum Lake for coloring drugs and cosmetics intended
for use in the area of the eye. This action is in response to a
petition filed by the Cosmetic, Toiletry, and Fragrance Association
(CTFA).
DATES: Effective February 17, 1994, except as to any provisions that
may be stayed by the filing of proper objections; written objections
and requests for a hearing by March 18, 1994.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Robert L. Martin, Center for Food
Safety and Applied Nutrition (HFS-217), Food and Drug Administration,
200 C St. SW. Washington, DC 20204, 202-254-9519.
SUPPLEMENTARY INFORMATION:
I. Introduction
In a notice published in the Federal Register of August 11, 1992
(57 FR 35833), FDA announced that a color additive petition (CAP
6C0206) had been filed by CTFA, 1101 17th St. NW., suite 300,
Washington, DC 20036. The petition proposed that the color additive
regulations for FD&C Blue No. 1 be amended to provide for the safe use
of FD&C Blue No. 1 and its lakes for coloring drugs and cosmetics
intended for use in the area of the eye. The petition was filed under
section 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379e). CTFA later amended the petition to limit the lakes requested for
eye area use to FD&C Blue No. 1 Aluminum Lake prepared in accordance
with Sec. 82.51 (21 CFR 82.51).
II. Definitions
Section 70.3(s) (21 CFR 70.3(s)) defines the term ``area of the
eye'' as ``the area enclosed within 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.'' The term ``lake'' is
defined in Sec. 70.3(l) as ``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.''
III. Background
Section 70.5(a) (21 CFR 70.5(a)) states that ``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.'' The regulations, in
Sec. 81.1 (21 CFR 81.1), state that the color additive lakes listed
therein may not be used in products that are intended to be used in the
area of the eye. The petitioner has requested that the uses for FD&C
Blue No. 1 and FD&C Blue No. 1 Aluminum Lake be expanded to include
uses in the area of the eye.
Part 82 (21 CFR part 82) lists the certified provisionally listed
colors and specifications and includes a description of, and
specifications for, the lakes that are permitted for use in foods
(Sec. 82.51) and in drugs and cosmetics (Sec. 82.1051). Sections 82.51
and 82.1051 list the acceptable lakes that can be combined with the
straight colors listed therein. The petitioner has requested that this
order be limited to the Aluminum Lake of FD&C Blue No. 1, prepared in
accordance with Sec. 82.51. Section 82.51 also limits the substrata
that can be used for FD&C lakes to alumina.
IV. Safety
In its evaluation of the safety of the proposed use of the subject
color additive, FDA has considered the safety data submitted previously
to support current listings for the use of FD&C Blue No. 1 in foods,
drugs, and cosmetics. FDA also evaluated ocular toxicity studies
submitted to support eye area use of the color additive and its
aluminum lake. FDA has determined that the petitioned use is safe,
because no adverse effects were found in these studies at levels
relevant to the petitioned use.
V. Conclusions
Based on data contained in the petition and other relevant
material, FDA concludes that there is a reasonable certainty that no
harm will result from the use of FD&C Blue No. 1 and FD&C Blue No. 1
Aluminum Lake as color additives in the area of the eye, and that the
additives are safe for their intended use. The agency also concludes on
the basis of available data that the color additive will perform its
intended effect and thus is suitable for the petitioned uses. The
agency, therefore, is amending the color additive regulations in
Secs. 74.1101(c) and 74.2101(c) (21 CFR 74.1101(c) and 74.2101(c)) to
provide for the use of FD&C Blue No. 1 and FD&C Blue No. 1 Aluminum
Lake in drugs and cosmetics, respectively, intended for use in the area
of the eye.
This document provides for the permanent listing of the aluminum
lake of FD&C Blue No. 1 for use in the area of the eye. Other uses of
the lakes of FD&C Blue No. 1 are provisionally listed under Secs. 81.1,
82.51, 82.101, and 82.1051. The agency notes that Secs. 74.1101(b)(2)
and 74.2101(b)(2) refer to Secs. 82.51 and 82.1051 for the
manufacturing process and specifications for the lakes of FD&C Blue No.
1. While the agency recognizes that this referral is to a section that
is designated as provisional, FDA considers this referral to be
appropriate because that section defines current good manufacturing
practice and provides appropriate specifications to ensure the quality
and purity of lakes made with the color additive. The agency has under
consideration an action to permanently list all lakes that have been
provisionally listed under parts 81 and 82. When that action is
completed, FDA intends to amend this referral as appropriate.
VI. Inspection of Documents
In accordance with Sec. 71.15 (21 CFR 71.15), the petition and the
documents that FDA considered and relied upon in reaching its decision
to list the petitioned uses are available for inspection at the Center
for Food Safety and Applied Nutrition (address above) by appointment
with the information contact person listed above. As provided in
Sec. 71.15, the agency will delete from the documents any materials
that are not available for public disclosure before making the
documents available for inspection.
VII. Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
VIII. Objections
Any person who will be adversely affected by this regulation may at
any time on or before March 18, 1994, file with the Dockets Management
Branch (address above) written objections thereto. Each objection shall
be separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. Three copies of all documents shall be
submitted and shall be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday. FDA will publish
notice of the objections that the agency has received or lack thereof
in the Federal Register.
List of Subjects in 21 CFR Part 74
Color additives, Cosmetics, Drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
74 is amended as follows:
PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
1. The authority citation for 21 CFR part 74 continues to read as
follows:
Authority: Secs. 201, 401, 402, 403, 409, 501, 502, 505, 601,
602, 701, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e).
2. Section 74.1101 is amended by revising paragraphs (b) and (c) to
read as follows:
Sec. 74.1101 FD&C Blue No. 1.
* * * * *
(b) Specifications. (1) The color additive FD&C Blue No. 1 for use
in coloring drugs generally shall conform in specifications to the
requirements of Sec. 74.101(b).
(2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance
with the requirements of Sec. 82.51 of this chapter.
(c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used
for coloring drugs, including drugs intended for use in the area of the
eye, in amounts consistent with current good manufacturing practice.
(2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring
drugs intended for use in the area of the eye, in amounts consistent
with current good manufacturing practice, subject to the restrictions
on the use of color additives in Sec. 70.5(b) and (c) of this chapter.
* * * * *
3. Section 74.2101 is amended by revising paragraphs (b) and (c) to
read as follows:
Sec. 74.2101 FD&C Blue No. 1.
* * * * *
(b) Specifications. (1) The color additive FD&C Blue No. 1 shall
conform in specifications to the requirements of Sec. 74.101(b).
(2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance
with the requirements of Sec. 82.51 of this chapter.
(c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used
for coloring cosmetics generally, including cosmetics intended for use
in the area of the eye, in amounts consistent with current good
manufacturing practice.
(2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring
cosmetics intended for use in the area of the eye, in amounts
consistent with current good manufacturing practice.
* * * * *
Dated: February 9, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-3554 Filed 2-15-94; 8:45 am]
BILLING CODE 4160-01-F