[Federal Register Volume 65, Number 153 (Tuesday, August 8, 2000)]
[Rules and Regulations]
[Pages 48375-48377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 97C-0415]


Listing of Color Additives Exempt From Certification; Luminescent 
Zinc Sulfide

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 luminescent zinc 
sulfide as a color additive in certain externally applied cosmetics. 
This action is in response to a petition filed by Zauder Bros., Inc.

DATES: This rule is effective September 8, 2000; except as to any 
provisions that may be stayed by the filing of proper objections. 
Submit written objections and requests for a hearing by September 7, 
2000.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Aydin O-AE4rstan, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3076.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of October 6, 1997 
(62 FR 52136), FDA announced that a color additive petition (CAP 
7C0251) had been filed by Zauder Bros., Inc., c/o Schiff & Co., 1129 
Bloomfield Ave.,

[[Page 48376]]

West Caldwell, NJ 07006. The petition proposed to amend the color 
additive regulations to provide for the safe use of zinc sulfide as a 
color additive in externally applied cosmetics. During its review of 
the petition, the agency determined that the subject color additive is 
zinc sulfide containing an added copper activator that produces a 
luminescent color. Therefore, the agency is establishing luminescent 
zinc sulfide as the common or usual name of the color additive.

II. Identity, Technical Effect, and Specifications

    Luminescent zinc sulfide is zinc sulfide containing 0.01 weight 
percent (100 parts per million) copper (Ref. 1). Copper functions as an 
activator. Following excitation by daylight or a suitable artificial 
light, luminescent zinc sulfide produces a yellow-green phosphorescence 
with a maximum at 530 nanometers (Ref. 1). The petitioner intends to 
use luminescent zinc sulfide in nail polishes and facial creams to 
produce a ``glow-in-the-dark'' effect.
    The luminescent zinc sulfide that is the subject of the petition 
contains 100#5 parts per million copper. To ensure that the 
color additive in finished products contains an effective level of 
copper consistent with the material identified in the petition, the 
agency is establishing the range of copper as 1005 
parts per million in new Sec. 73.2995(b).
    In addition to copper, other activators, for example cobalt, may 
also be added to zinc sulfide to obtain pigments with different 
phosphorescent properties (Ref. 1). However, the petitioner did not 
request the listing of zinc sulfide containing activators other than 
copper and the petition contains no relevant safety data. Therefore, 
phosphorescent zinc sulfide pigments containing activators other than 
copper are not covered by this final rule.

III. Safety Evaluation

    The petitioner proposed to use luminescent zinc sulfide in nail 
polishes and specialized facial makeup preparations for use on limited 
occasions such as Halloween. The agency reviewed the data in the 
petition and determined that luminescent zinc sulfide is not a dermal 
irritant or dermal sensitizer. The agency also reviewed two skin 
absorption studies in the petition. The agency determined that these 
studies showed an apparent low skin absorption of luminescent zinc 
sulfide, and that the petitioned use of luminescent zinc sulfide in 
facial makeup preparations is safe (Ref. 2). However, the agency also 
determined that these absorption studies were limited in their ability 
to measure skin absorption under all conditions of use. Therefore, new 
Sec. 73.2995(c)(2) restricts the use of facial makeup preparations 
containing luminescent zinc sulfide to limited occasions (e.g., 
Halloween). In other words, under new Sec. 73.2995(c)(2), facial makeup 
preparations containing luminescent zinc sulfide are not intended for 
regular or daily use. Furthermore, based on the luminescent zinc 
sulfide concentrations in facial makeup preparations stated in the 
petition, new Sec. 73.2995(c)(1) limits the amount of luminescent zinc 
sulfide in facial makeup preparations to 10 percent by weight of the 
final product. The agency notes that luminescent zinc sulfide in nail 
polish would be bound in the polish once it dries on the nail, and 
hence, the skin contact of luminescent zinc sulfide would be minimal. 
Therefore, the agency concludes that a limit on the amount of 
luminescent zinc sulfide in nail polishes is not necessary for safety 
reasons.
    Because the agency is approving the color additive only for limited 
applications, new Sec. 73.2995(c) provides clear identification of the 
approved uses. The agency is limiting the approved uses of luminescent 
zinc sulfide to specific cosmetic product categories listed in 
Sec. 720.4(c) (21 CFR 720.4). These product categories were proposed by 
the cosmetics industry in a petition to the agency to establish an FDA-
administered Voluntary Cosmetic Registration Program (VCRP). FDA 
adopted these product categories in 1972 with the establishment of the 
VCRP (37 FR 7151, April 11, 1972). The agency has determined that 
referencing the relevant product categories in Sec. 720.4(c) more 
clearly identifies the products in which use of luminescent zinc 
sulfide has been approved. Section 720.4(c) includes a category for 
nail polish (Sec. 720.4(c)(8)(v), Nail polish and enamel). Although 
Sec. 720.4(c) does not include a specific category for facial makeup 
preparations for the specialty use that was proposed in the petition, 
it includes a category, other makeup preparations 
(Sec. 720.4(c)(7)(ix)), which includes this use. Referencing this 
cosmetic product category in the regulation effectively restricts it 
from being used in all other categories listed under Sec. 720.4(c)(7), 
for which use of the color additive was not approved. The agency finds 
that references to the cosmetic product categories for the approved 
uses, together with the specific limitations in new Sec. 73.2995(c)(1) 
and (c)(2) on the use of luminescent zinc sulfide in facial makeup 
preparations, will effectively define the uses that the agency has 
reviewed and determined to be safe.
    The petition does not request use of luminescent zinc sulfide in 
the area of the eye, and therefore, contains no data to support the use 
of luminescent zinc sulfide applied to the area of the eye. Therefore, 
the agency is not including eye area use of luminescent zinc sulfide in 
new Sec. 73.2995. However, because the probable use of facial makeup 
preparations would include use on children's faces at Halloween, the 
agency is concerned about the potential for the inappropriate use of 
these preparations in the area of the eye. Therefore, new 
Sec. 73.2995(d)(2) requires the following statement on the product 
label: ``Do not use in the area of the eye.''

IV. Conclusion

    Based on the data in the petition and other relevant material, FDA 
concludes that the proposed use of luminescent zinc sulfide as a color 
additive in nail polishes and specialized facial makeup preparations is 
safe, the additive will achieve its intended technical effect, and 
therefore, part 73 should be amended as set forth below. In addition, 
based upon the factors listed in 21 CFR 71.20(b), the agency concludes 
that certification of luminescent zinc sulfide is not necessary for the 
protection of the public health.

V. 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 approve the petition 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.

VI. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for CAP 7C0251 (62 FR 
52136, October 6, 1997). No new information or comments have been 
received that would affect the agency's previous determination that 
there is no significant impact on the human environment and that an 
environmental impact statement is not required.

[[Page 48377]]

VII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VIII. Objections

    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (address above) 
written objections by September 7, 2000. 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 are to be 
submitted and are to 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.

IX. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. Murayama, Y., ``Luminous Paints,'' in S. Shionoya, and W. M. 
Yen, editors, Phosphor Handbook, pp. 651, 655-656, CRC Press, Boca 
Raton, FL, 1999.
    2. Yourick, J. J., memorandum entitled ``Review of Toxicology 
Studies Contained in CAP7C0251, Use of Zinc Sulfide as a Color 
Additive in Cosmetics'' from the Cosmetics Toxicology Branch (HFS-
128) to Aydin O-AE4rstan, Direct Additives Branch (HFS-215), Center 
for Food Safety and Applied Nutrition, FDA, March 14, 2000.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

    1. The authority citation for 21 CFR part 73 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.
    2. Section 73.2995 is added to subpart C to read as follows:


Sec. 73.2995  Luminescent zinc sulfide.

    (a) Identity. The color additive luminescent zinc sulfide is zinc 
sulfide containing a copper activator. Following excitation by daylight 
or a suitable artificial light, luminescent zinc sulfide produces a 
yellow-green phosphorescence with a maximum at 530 nanometers.
    (b) Specifications. Luminescent zinc sulfide shall conform to the 
following specifications and shall be free from impurities other than 
those named to the extent that such impurities may be avoided by good 
manufacturing practice:

    Zinc sulfide, not less than 99.8 percent.
    Copper, 100#5 parts per million.
    Lead, not more than 20 parts per million.
    Arsenic, not more than 3 parts per million.
    Mercury, not more than 1 part per million.
    Cadmium, not more than 15 parts per million.

    (c) Uses and restrictions. The color additive luminescent zinc 
sulfide may be safely used for coloring externally applied facial 
makeup preparations (included under Sec. 720.4(c)(7)(ix) and (c)(8)(v) 
of this chapter) subject to the following restrictions:
    (1) The amount of luminescent zinc sulfide in facial makeup 
preparations shall not exceed 10 percent by weight of the final 
product.
    (2) Facial makeup preparations containing luminescent zinc sulfide 
are intended for use only on limited, infrequent occasions, e.g., 
Halloween, and not for regular or daily use.
    (d) Labeling requirements. (1) The label of the color additive and 
any mixtures prepared therefrom shall bear expiration dates for the 
sealed and open container (established through generally accepted 
stability testing methods), other information required by Sec. 70.25 of 
this chapter, and adequate directions to prepare a final product 
complying with the limitations prescribed in paragraph (c) of this 
section.
    (2) The label of a facial makeup preparation containing the color 
additive shall bear, in addition to other information required by the 
law, the following statement conspicuously displayed:
    Do not use in the area of the eye.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification 
requirements of section 721(c) of the act.

    Dated: August 1, 2000.
Janice F. Oliver,
Deputy Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 00-19952 Filed 8-7-00; 8:45 am]
BILLING CODE 4160-01-F