[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