[Federal Register Volume 71, Number 106 (Friday, June 2, 2006)]
[Rules and Regulations]
[Pages 31927-31929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8575]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 1998C-0790] (formerly 98C-0790)


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 titanium dioxide 
coated mica-based pearlescent pigments as color additives in food. This 
action is in partial response to a petition filed by EM Industries, 
Inc.

DATES: This rule is effective July 5, 2006. Submit written or 
electronic objections and requests for a hearing by July 3, 2006. See 
section VIII of the SUPPLEMENTARY INFORMATION section of this document 
for information on the filing of objections.

ADDRESSES: You may submit written or electronic objections and requests 
for a hearing, identified by Docket No. 1998C-0790, by any of the 
following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All objections received 
will be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For detailed 
instructions on submitting objections, see the ``Objections'' heading 
of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
objections received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

[[Page 31928]]


FOR FURTHER INFORMATION CONTACT: Paul C. DeLeo, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1302.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of September 25, 1998 
(63 FR 51359), FDA announced that a color additive petition (CAP 
8C0262) had been filed by EM Industries, Inc., 7 Skyline Dr., 
Hawthorne, NY 10532 (now EMD Chemicals, Inc.). The petition proposed to 
amend the color additive regulations to provide for the safe use of 
synthetic iron oxide and mica to color food and to provide for the safe 
use of titanium dioxide to color food at levels higher than the current 
limit. At the time of the filing of the petition, FDA considered the 
pigments that are the subjects of this petition to be color additive 
mixtures of synthetic iron oxide, mica, and titanium dioxide. During 
its subsequent review of the petition, the agency determined that these 
pigments are composite pigments, not color additive mixtures. 
Therefore, the agency published an amended filing notice in the Federal 
Register of June 21, 1999 (64 FR 33097), to indicate that the petition 
proposed to amend the color additive regulations to provide for the 
safe use of composite pigments prepared from synthetic iron oxide, 
mica, and titanium dioxide to color food. This final rule is a partial 
response to the petition and addresses only the composite pigments 
prepared from mica and titanium dioxide to color food. The remaining 
composite pigments containing synthetic iron oxide included in the 
petition remain under review.
    The petitioner is seeking approval for a maximum use level of the 
resulting pigments of up to 1.25 percent by weight in food. The 
categories of food identified in the petition to which mica-based 
pearlescent pigments would be added are cereals, confections and 
frostings, gelatin desserts, hard and soft candies (including 
lozenges), nutritional supplement tablets and gelatin capsules, and 
chewing gum.

II. Manufacturing and Nomenclature

    The subject color additive is manufactured by preparing a 
suspension of mica platelets, then adding a solution of soluble salts 
of titanium and a basic solution to precipitate titanium hydroxide onto 
the mica platelets. These particles are then heated (calcined) at 
temperatures up to 900 [deg]C. During the calcination, titanium 
hydroxide is converted into titanium dioxide. The agency has reviewed 
the relevant data and information in the petition relating to the 
manufacture and identity of the subject color additive (Ref. 1), and to 
the proposed uses of and estimated exposure to the subject color 
additive (Refs. 2, 3, and 4).
    In a final rule published in the Federal Register of October 24, 
2002 (67 FR 65311), the agency listed the color additives based on 
titanium or iron salts and mica platelets for use in contact lenses in 
Sec.  73.3128 (21 CFR 73.3128). In the same final rule, the agency 
collectively identified these color additives as mica-based pearlescent 
pigments. In addition, in the Federal Register of July 22, 2005 (70 FR 
42271), the agency published a final rule to amend the color additive 
regulations to provide for the use of mica-based pearlescent pigments 
as color additives, in amounts up to 3 percent by weight, in ingested 
drugs by adding Sec.  73.1128 (21 CFR 73.1128). To be consistent with 
these actions, the agency is using the same name for the color additive 
that is the subject of the present rule.

III. Safety Evaluation

    To evaluate the safety of the proposed use of titanium dioxide 
coated mica-based pearlescent pigments for coloring food, the agency 
reviewed the toxicological data and information submitted in the 
petition as well as other information contained in agency files (Ref. 
5).
    To determine whether a color additive in food is safe under its 
proposed conditions of use, FDA considers the projected human dietary 
intake of the additive, toxicological data on the additive, and other 
relevant information (such as published literature) available to the 
agency. FDA compares an individual's estimated daily intake (EDI) of 
the additive from all sources to an acceptable daily intake (ADI) 
established by toxicological data. The EDI is determined by projections 
based on the amount of the additive proposed for use in particular 
foods and on data regarding the amount consumed from all sources of the 
additive. The agency commonly uses the EDI of the additive from 
consumption of food at the 90th percentile as a measure of high chronic 
dietary intake.
    FDA estimates the EDI of mica-based pearlescent pigments from all 
the petitioned uses in food (except nutritional supplements in tablet 
and gelatin capsule form) for consumers aged 2 years or more at the 
90th percentile to be 0.86 grams per person per day (g/p/d) (Ref. 3). 
The agency also considered the exposure to the color additive from its 
uses in ingested drugs, nutritional supplements in tablet and gelatin 
capsule form, and contact lenses. The estimated intake of the pigments 
from their use in ingested drugs and nutritional supplements is 
approximately one-eighth of the intake from their proposed use in food 
(Ref. 4). The exposure to the components of mica-based pearlescent 
pigments from the use of the pigments in contact lenses is negligible 
compared to the intake from their use in ingested drugs or food (Ref. 
5).
    As part of the FDA's safety evaluation, the agency selected a life-
time rodent bioassay submitted with the petition as the pivotal study. 
During the study, a blend of two titanium dioxide-coated mica-based 
pearlescent pigments was fed to rats at levels up to 5 percent in the 
feed for up to 2 years (Ref. 5). The agency determined that the results 
of the study showed no indications of adverse effects in rats from the 
prolonged consumption of the pigments at any of the doses tested. FDA 
concluded that the no-observed-effect level (NOEL) based on the highest 
dose tested in this study is over 3,000 mg/kg body-weight/day. By 
applying a 100-fold safety factor to this NOEL, the agency calculated 
the ADI for titanium dioxide-coated mica-based pearlescent pigments for 
a 60 kg human as 1.8 g/p/d. Therefore, taking into account the 
available safety information, and the conservative estimates of intake 
of the additives, the agency concludes that the proposed use of 
titanium dioxide-coated mica-based pearlescent pigments to color food 
is safe.

IV. Conclusion

    Based on the data and information in the petition and other 
relevant material, FDA concludes that the petitioned use of mica-based 
pearlescent pigments prepared from titanium salts and mica to color 
food is safe. The agency further concludes that the additive will 
achieve its intended technical effect, and is suitable for use in 
coloring food. The agency also concludes that 21 CFR part 73 of the 
color additive regulations should be amended as set forth in this 
document. In addition, based upon the factors listed in Sec.  71.20(b) 
(21 CFR 71.20(b)), the agency concludes that certification of these 
titanium dioxide-coated 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

[[Page 31929]]

petition are available for inspection at the Center for Food Safety and 
Applied Nutrition by appointment with the information contact person 
(see FOR FURTHER INFORMATION CONTACT). 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 and amended filing 
notice for CAP 8C0262 (63 FR 51359 and 64 FR 33097). 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

    This rule is effective as shown in the DATES section of this 
document, except as to any provisions that may be stayed by the filing 
of proper objections. Any person who will be adversely affected by this 
regulation may file with the Division of Dockets Management (see 
ADDRESSES) written or electronic objections. 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 Division of Dockets 
Management 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 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Memorandum from Jensen, Chemistry Review Team, Division of 
Product Manufacture and Use, to Orstan, Division of Petition 
Control, January 22, 1999.
    2. Memorandum from Lee, Chemistry Review Group, Division of 
Petition Review, to Orstan, Regulatory Group II, Division of 
Petition Review, April 16, 2003.
    3. Memorandum from Lee, Chemistry Review Group, Division of 
Petition Review, to DeLeo, Regulatory Group II, Division of Petition 
Review, March 1, 2005.
    4. Memorandum from Lee, Chemistry Review Group, Division of 
Petition Review, to Orstan, Regulatory Group II, Division of 
Petition Review, January 30, 2003.
    5. Memorandum from Park, Toxicology Review Group I, Division of 
Petition Review, to DeLeo, Division of Petition Review, December 14, 
2005.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act (the act) and 
under the authority delegated to the Commissioner of Food and Drugs, 21 
CFR part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
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.


0
2. Section 73.350 is added to subpart A to read as follows:


Sec.  73.350  Mica-based pearlescent pigments.

    (a) Identity. (1) The color additive is formed by depositing 
titanium salts onto mica, followed by heating to produce titanium 
dioxide on mica. Mica used to manufacture the color additive shall 
conform in identity to the requirements of Sec.  73.1496(a)(1).
    (2) Color additive mixtures for food use made with mica-based 
pearlescent pigments may contain only those diluents listed in this 
subpart as safe and suitable for use in color additive mixtures for 
coloring food.
    (b) Specifications. Mica-based pearlescent pigments shall conform 
to the following specifications and shall be free from impurities other 
than those named to the extent that such other impurities may be 
avoided by good manufacturing practice:
    (1) Lead (as Pb), not more than 4 parts per million (ppm).
    (2) Arsenic (as As), not more than 3 ppm.
    (3) Mercury (as Hg), not more than 1 ppm.
    (c) Uses and restrictions. (1) The substance listed in paragraph 
(a) of this section may be safely used as a color additive in amounts 
up to 1.25 percent, by weight, in the following foods:
    (i) Cereals.
    (ii) Confections and frostings.
    (iii) Gelatin desserts.
    (iv) Hard and soft candies (including lozenges).
    (v) Nutritional supplement tablets and gelatin capsules.
    (vi) Chewing gum.
    (2) The color additive may not be used to color foods for which 
standards of identity have been issued under section 401 of the act, 
unless the use of the added color is authorized by such standards.
    (d) Labeling. The label of the color additive and of any mixture 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (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: May 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8575 Filed 6-1-06; 8:45 am]
BILLING CODE 4160-01-S