Document ID: FDA-2008-C-0098-0003
Agency: fda
Document Type: Rule
Title: Listing of Color Additives Exempt From Certification: Bismuth Citrate
Posted Date: 2010-03-26T04:00Z

[Federal Register: March 26, 2010 (Volume 75, Number 58)]
[Rules and Regulations]               
[Page 14491-14493]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr10-2]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2008-C-0098]

 
Listing of Color Additives Exempt From Certification; Bismuth 
Citrate

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 increase the permitted use level of bismuth 
citrate as a color additive in cosmetics intended for coloring hair on 
the scalp. This action is in response to a petition filed by Combe, 
Inc.

DATES:  This rule is effective April 27, 2010; except as to any 
provisions that may be stayed by the filing of proper objections. 
Submit electronic or written objections and requests for a hearing by 
April 26, 2010. See section VII 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. FDA-2008-C-0098, by 
any of the following methods:
Electronic Submissions
    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written objections 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.
    Instructions: All submissions received must include the agency name 
and

[[Page 14492]]

docket number for this rulemaking. All objections received will be 
posted without change to http://www.regulations.gov, 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.regulations.gov 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.

FOR FURTHER INFORMATION CONTACT:  Felicia M. Ellison, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1264.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of February 25, 2008 
(73 FR 10035), FDA announced that a color additive petition (CAP 
8C0286) had been filed by Combe, Inc., c/o EAS Consulting Group, LLC, 
1940 Duke St., suite 200, Alexandria, VA 22314. The petition proposed 
to amend the color additive regulations in Sec.  73.2110 Bismuth 
citrate (21 CFR 73.2110) by increasing the maximum permitted use level 
of bismuth citrate as a color additive in cosmetics intended for 
coloring hair on the scalp from 0.5 percent (weight per volume (w/v)) 
to 2.0 percent (w/v).

II. Evaluation of Safety

A. Determination of Safety

    Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 379e(b)(4)), a color additive may not be listed 
for a particular use unless a fair evaluation of the data and 
information available to FDA establishes that the color additive is 
safe for that use. FDA's color additive regulations at Sec.  70.3(i) 
(21 CFR 70.3(i)) define safe as the existence of ``convincing evidence 
that establishes with reasonable certainty that no harm will result 
from the intended use of the color additive.''

B. Safety of the Petitioned Use of the Color Additive

    The petition proposes to increase the level of bismuth citrate in 
cosmetics intended for coloring scalp hair to 2.0 percent (w/v) with no 
changes to the identity or to the specifications of the color additive 
listed in Sec.  73.2110. Consequently, the agency's current review 
focused on whether there are any safety concerns from the proposed 
increased use level of the color additive.
    To assess the safety from use of bismuth citrate at a level of 2.0 
percent (w/v) in cosmetic hair coloring products, FDA estimated the 
potential exposure to the color additive based on conservative 
assumptions. Directions on a sample label for a hair coloring product 
containing the color additive recommend that the product be applied 
daily until the hair reaches the desired color (estimated by the 
petitioner to be 2 to 3 weeks), followed by a maintenance regimen where 
the product is applied several times a week. The petitioner contends 
that the maintenance regimen is most representative of long-term use of 
bismuth citrate for coloring hair. FDA agrees with the petitioner and 
used the maintenance regimen to estimate chronic exposure to the color 
additive. Information in the petition indicates that 10 milliliters of 
the hair cosmetic product applied three times per week represents the 
maximum recommended use for the maintenance regimen. Of the amount 
applied, 2.0 percent of the hair coloring product is expected to reach 
the scalp and of that, 2.71 percent of the product is expected to be 
absorbed through the skin, resulting in an estimated potential exposure 
to the color additive of 46.5 micrograms per person per day (Ref. 1).
    To show that the requested increased use level of bismuth citrate 
would be safe, the petitioner provided results from a 90-day oral 
toxicity study on bismuth citrate in rats, genotoxicity studies, dermal 
penetration studies, and dermal photosensitization studies. The dermal 
penetration studies showed no evidence of detectable systemic 
absorption of bismuth citrate, and the in vitro (pig skin) dermal 
penetration study revealed only minimal (2.71 percent) absorption in 
the epidermis. Neither study showed any evidence that bismuth citrate 
was a dermal- or photo-sensitizer. The 90-day oral feeding study showed 
no evidence of toxicity at 30 milligrams per kilogram body weight per 
day, which is more than 38,000 times greater than the estimated level 
of exposure (Ref. 2). Based on the totality of data and information 
submitted by the petitioner, FDA concludes that the expected exposure 
to the color additive from the proposed increased use level is safe.

III. Conclusion

    FDA reviewed data in the petition and other available relevant 
material to evaluate the safety of the use of bismuth citrate as a 
color additive in cosmetics intended for coloring hair on the scalp. 
Based on this information, the agency concludes that the proposed 
increased use level of the color additive is safe and that the color 
additive will achieve its intended technical effect. Therefore, the 
regulations in part 73 (21 CFR part 73) 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 
bismuth citrate is not necessary for the protection of the public 
health.

IV. Public Disclosure

    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 will be made available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person listed above (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.

V. 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 Division 
of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

VI. Paperwork Reduction Act of 1995

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

VII. 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 at any time file with the Division of Dockets Management 
(see ADDRESSES) electronic or written objections. Each objection shall 
be separately numbered, and each numbered objection shall specify with 
particularity the provisions of the

[[Page 14493]]

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.

VIII. 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 D. Folmer, Division of Petition Review, to F. 
Ellison, Division of Petition Review, January 30, 2009.
    2. Memorandum from A. Khan, Division of Petition Review, to F. 
Ellison, Division of Petition Review, April 23, 2009.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

0
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

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 73.2110 is amended by revising paragraph (c)(1) to read as 
follows:

Sec.  73.2110   Bismuth citrate.

* * * * *
    (c) * * *
    (1) The amount of bismuth citrate in the cosmetic shall not be in 
excess of 2.0 percent (w/v).
* * * * *

    Dated: March 17, 2010.
Leslye M. Fraser,
Director, Office of Regulations, Policy and Social Sciences, Center for 
Food Safety and Applied Nutrition.
[FR Doc. 2010-6731 Filed 3-25-10; 8:45 am]
BILLING CODE 4160-01-S