[Federal Register Volume 67, Number 206 (Thursday, October 24, 2002)]
[Rules and Regulations]
[Pages 65311-65312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27048]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 00C-1321]


Listing of Color Additives Exempt From Certification; Mica-Based 
Pearlescent Pigments

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 mica-based 
pearlescent pigments as color additives in contact lenses. This action 
is in response to a petition filed by Wesley Jessen Corp.

DATES: This regulation is effective November 26, 2002. Submit written 
or electronic objections and requests for a hearing by November 25, 
2002. See Section VIII of the SUPPLEMENTARY INFORMATION section of this 
document for information on the filing of objections.

ADDRESSES: Submit written or electronic objections to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Aydin [Ouml]rstan, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 202-418-3076.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of June 7, 2000 (65 
FR 36148), FDA announced that a color additive petition (CAP 0C0271) 
had been filed by Wesley Jessen, Corp., 333 East Howard Ave., Des 
Plaines, IL 60018 (now Ciba Vision Corp., 11460 Johns Creek Pkwy., 
Duluth, GA 30097-1556). The petition proposed to amend the color 
additive regulations in part 73 (21 CFR part 73 subpart D--Medical 
Devices) to provide for the safe use of mica to color contact lenses. 
During its subsequent review of the petition, the agency determined 
that the subject color additives are composite pigments composed of 
mica coated with iron oxides or mica coated with titanium dioxide. 
Therefore, in the Federal Register of May 20, 2002 (67 FR 35551), the 
agency published an amended filing notice to state that the petition 
proposes that the color additive regulations be amended to provide for 
the safe use of mica coated with iron oxides or mica coated with 
titanium dioxide, collectively identified as mica-based pearlescent 
pigments, in contact lenses.

II. Identity and Manufacturing

    Mica-based pearlescent pigments consist of either mica platelets 
coated with titanium dioxide or mica platelets coated with iron oxides. 
These color additives are manufactured by preparing a suspension of 
mica platelets, and then adding a solution of a soluble salt of 
titanium or of iron, and a base to precipitate titanium hydroxide or 
iron hydroxide onto the mica platelets. These particles are heated 
(calcined) at 800 to 900 [deg]C to obtain mica coated with titanium 
dioxide or mica coated with iron oxides. These color additives create a 
pearlescent effect and are known commonly as pearlescent pigments. 
Therefore, the agency is establishing mica-based pearlescent pigments 
as the common or usual name of the color additives.

III. Safety Evaluation

    During its review of the safety of the use of mica-based 
pearlescent pigments in contact lenses, the agency considered the 
exposure to the color additives from the petitioned use. The agency 
notes that it is highly unlikely that the color additives or their 
components would migrate out of the contact lens into the aqueous 
environment of the eye, because: (1) These pigments are insoluble in 
aqueous media, and (2) they are an integral part of the contact lens. 
Therefore, the agency concludes that the exposure to the components of 
the color additives, including any impurities that may be present in 
them, from the petitioned use would be negligible (Ref. 1).
    The agency notes that two of the components of the color additives, 
iron oxides (Sec.  73.3125) and titanium dioxide (Sec.  73.3126), 
already are listed for use as color additives in contact lenses. 
Therefore, the agency concludes that the use of iron oxides or titanium 
dioxide in mica-based pearlescent pigments does not present a safety 
concern (Ref. 2).
    Although mica currently is not regulated for use as a color 
additive in contact lenses, it has been approved for safe use in 
coloring cosmetics generally, including those applied to the area of 
the eye, including the eyeball (Sec. Sec.  73.2496 and 70.3(s)). 
Generally, the toxicological tests the agency requires to demonstrate 
that a color additive is safe for use in coloring cosmetics applied to 
the eye area are adequate to support the safety of a color additive 
used in contact lenses. In both cases, the tests must show that the 
color additive is safe and not expected to cause adverse effects under 
the conditions of use. This is reflected in the agency's current 
guidance document for contact lens manufacturers (Ref. 3).
    In this case, the toxicological data which supported the approval 
of mica for use in eye area cosmetics are sufficient to support the 
safe use of mica in contact lenses. These data showed that instillation 
of a solution containing 5-percent mica directly into the eyes of 
rabbits did not produce any evidence of ocular or iridial irritation 
(Ref. 4). In contrast to this exaggerated and direct exposure to mica 
in the eye, the exposure to mica from its proposed use in contact 
lenses would be negligible, and if any incidental exposure to mica were 
to occur, it would not be a safety concern. Therefore, the agency 
concludes that mica also may be used safely to color contact lenses 
(Ref. 2).
    The regulations listing mica for use in coloring drugs (Sec.  
73.1496) and cosmetics (Sec.  73.2496) provide specifications to ensure 
the safe use of mica in those products. To ensure that the mica used in 
the manufacture of mica-based pearlescent pigments is of comparable 
purity to the already regulated mica, the agency is requiring in new 
Sec.  73.3128 that mica used to manufacture the color additives meet 
the identity and specifications for mica in Sec.  73.1496. The agency 
also has considered the need to establish purity specifications for the 
mica-based pearlescent pigments. As noted previously, the agency has 
determined that the exposure to the components of mica-based 
pearlescent pigments, including any impurities that may be present in 
them from the petitioned use, would be negligible. Given the negligible 
exposure to the color additive and the specifications that are being 
established for the mica component of the color additive, the agency 
concludes that it is not necessary to establish separate specifications 
for the mica-based pearlescent pigments in new Sec.  73.3128.

IV. Conclusion

    Based on the data in the petition and other relevant material, FDA 
concludes that the petitioned use of mica-based pearlescent pigments as 
color additives in contact lenses is safe, the additives will achieve 
their intended technical effects, and thus, are suitable for this use. 
The agency concludes that part 73 should be amended as set forth in 
this document. In addition, based upon the factors listed in 21 CFR 
71.20(b), the

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agency concludes that certification of mica-based pearlescent pigments 
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 by appointment with the information 
contact person. 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 0C0271 (65 FR 
36148, June 7, 2000). 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.

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 
file with the Dockets Management Branch (see ADDRESSES) written 
objections by (see DATES). 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.

IX. References

    1. Carberry, S. E., memorandum entitled ``Use of Mica-Based 
Pearlescent Pigments as Colorants for Contact Lenses'' from the 
Division of Petition Review (HFS-265) to the Division of Petition 
Review (HFS-265), Center for Food Safety and Applied Nutrition, FDA, 
March 28, 2002.
    2. Johnson, C. B., memorandum entitled ``Use of Mica-Based 
Pearlescent Pigments to Color Contact Lenses: Toxicology Review'' 
from the Division of Petition Review (HFS-225) to the Division of 
Petition Review (HFS-215), Center for Food Safety and Applied 
Nutrition, FDA, November 9, 2001.
    3. Center for Devices and Radiological Health, Premarket 
Notification (510(k)) Guidance Document for Daily Wear Contact 
Lenses, Addendum to Chemistry Guidance for Listing Color Additives 
in Contact Lenses, Part 5, p.149, (http://www.fda.gov/cdrh/ode/conta.html) May 1994.
    4. Gittes, H. R., memorandum entitled ``Eye Area Studies'' from 
the Division of Toxicology (HFF-152) to the Petitions Control Branch 
(HFF-334), Center for Food Safety and Applied Nutrition, FDA, May 
17, 1977.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, 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 73.3128 is added to subpart D to read as follows:


Sec.  73.3128  Mica-based pearlescent pigments.

    (a) Identity and specifications. The color additive is formed by 
depositing titanium or iron salts from a basic solution onto mica, 
followed by calcination to produce titanium dioxide or iron oxides on 
mica. Mica used to manufacture the color additive shall conform in 
identity and specifications to the requirements of Sec.  73.1496(a)(1) 
and (b).
    (b) Uses and restrictions. (1) Mica-based pearlescent pigments 
listed in paragraph (a) of this section may be used as a color additive 
in contact lenses in amounts not to exceed the minimum reasonably 
required to accomplish the intended coloring effect.
    (2) Authorization and compliance with this use shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with 
respect to the contact lenses in which the additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements in Sec.  70.25 of this chapter.
    (d) 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: September 30, 2002.
L. Robert Lake,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 02-27048 Filed 10-23-02; 8:45 am]
BILLING CODE 4160-01-S