2010-6731. Listing of Color Additives Exempt From Certification; Bismuth Citrate

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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: [phone].
• 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 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 § 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 § 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 § 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 § 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 § 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 § 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 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

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

§ 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.