[Federal Register Volume 72, Number 117 (Tuesday, June 19, 2007)]
[Rules and Regulations]
[Pages 33664-33667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11801]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. 1995C-0286 (formerly Docket No. 95C-0286)]


Listing of Color Additives Subject to Certification; D&C Black 
No. 3

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 D&C Black No. 3 
(bone black, subject to FDA batch certification) as a color additive in 
eyeliner, eye shadow, mascara, and face powder. This action is in 
response to a petition filed by Ebonex Corp.

DATES: This rule is effective July 20, 2007. Submit written or 
electronic objections and requests for a hearing by July 19, 2007. 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 1995C-0286, by any of the 
following methods:
Electronic Submissions
    Submit electronic objections 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 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.
    To ensure more timely processing of objections, FDA is no longer 
accepting objections submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic objections 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 number 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.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1071.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of September 1, 1995 
(60 FR 45724), FDA announced that a color additive petition (CAP 
5C0247) had been filed by the Ebonex Corp., P.O. Box 3247, Melvindale, 
MI 48122. The petition proposed to amend the color additive regulations 
to provide for the safe use of bone black as a color additive in 
cosmetics, including cosmetics intended for use in the eye area. The 
petitioner subsequently narrowed the proposed uses of bone black to 
eyeliner, eye shadow, mascara, and face powder.
    During its review of the petition, the agency determined that the 
color additive, bone black, will require batch certification by FDA. 
The agency intends to give each certified batch of the subject color 
additive the name D&C Black No. 3. Therefore, this color additive will 
be identified as D&C Black No. 3.
    The requested use of D&C Black No. 3 includes cosmetics for use in 
the area of the eye. The term ``area of the eye'' is defined in Sec.  
70.3(s) (21 CFR 70.3(s)) as ``the area enclosed within the 
circumference of the supra-orbital ridge and the infra-orbital ridge, 
including the

[[Page 33665]]

eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and 
conjunctival sac of the eye, the eyeball, and the soft areolar tissue 
that lies within the perimeter of the infra-orbital ridge.''
    Section 70.5(a) (21 CFR 70.5(a)) states that ``No listing or 
certification of a color additive shall be considered to authorize the 
use of any such color additive in any article intended for use in the 
area of the eye unless such listing or certification of such color 
additive specifically provides for such use.''

II. Identity and Specifications

    D&C Black No. 3 is a black pigment made from calcined cattle bones. 
The bones are heated twice to temperatures in excess of 700[deg]C for 
at least 6 hours each time. The twice burned char is then washed. The 
carbon content is approximately 8 percent to 10 percent and most of the 
remaining composition is tricalcium phosphate (as calcium 
hydroxyapatite).
    As explained under section III.B of this document, D&C Black No. 3 
may contain low levels of potentially carcinogenic polycyclic aromatic 
hydrocarbon (PAH) impurities. To limit the amounts of these impurities 
in the color additive, FDA is setting a specification for total PAHs 
and is requiring that D&C Black No. 3 be from a batch of bone black 
certified by FDA.
    To limit the amounts of heavy metals in the color additive, which 
may be derived from the source of the color and the manufacturing 
process, the agency also is setting specifications for arsenic and 
lead. To ensure purity of the color additive, the agency also is 
setting specifications for carbon, calcium hydroxyapatite, moisture, 
and silica. To be used lawfully in cosmetics in the United States, all 
batches of bone black must meet the specifications identified in the 
regulation.

III. Safety Evaluation

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)), the ``general safety standard'' for 
color additives, a color additive cannot 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 (Sec.  70.3(i)) define safe as ``convincing 
evidence that establishes with reasonable certainty that no harm will 
result from the intended use of the color additive.''
    The anticancer clause of the color additive amendments (section 
721(b)(5)(B) of the act), also known as the Delaney clause) provides 
that for any use of a color additive which will or may result in 
ingestion of all or part of such additive, the color additive shall be 
deemed to be unsafe and shall not be listed if the additive is found to 
induce cancer when ingested by man or animal, or if it is found, after 
tests which are appropriate for the evaluation of the safety of 
additives for use in food, to induce cancer in man or animal (section 
721(b)(5)(B)(i) of the act). Further, under section 721(b)(5)(B)(ii) of 
the act, for any use of a color additive which will not result in 
ingestion of any part of such additive, the color additive shall be 
deemed to be unsafe and shall not be listed if, after tests which are 
appropriate for the evaluation of the safety of additives for such use, 
or after other relevant exposure of man or animal to such additive, it 
is found to induce cancer in man or animal.
    Importantly, however, the Delaney clause applies to the additive 
itself and not to impurities in the additive. That is, where an 
additive itself has not been shown to cause cancer, but contains a 
carcinogenic impurity, the additive is properly evaluated under the 
general safety standard using risk assessment procedures to determine 
whether there is a reasonable certainty that no harm will result from 
the intended use of the additive (Scott v.FDA, 728 F.2d 322 (6th Cir. 
1984)).

B. Safety of Petitioned Use of the Additive

    Because D&C Black No. 3 is made from cattle bones, one potential 
safety concern is the risk from using cattle materials in the 
preparation of bone black that could be infected with the agent that 
causes Bovine Spongiform Encephalopathy (BSE). To address the potential 
risk of BSE, FDA prohibits the use of certain cattle materials in human 
food and cosmetics. FDA also requires that manufacturers and processors 
of human food and cosmetics that are manufactured from, processed with, 
or otherwise contain, material from cattle establish and maintain 
records sufficient to demonstrate that the human food or cosmetic is 
not manufactured from, processed with, or does not otherwise contain, 
prohibited cattle materials (21 CFR 189.5 and 700.27). FDA's regulatory 
measures to prevent BSE contamination of U.S. food and cosmetics ensure 
that cattle materials that carry the highest risk of transmitting the 
agent that causes BSE are excluded from being used as a source to 
produce D&C Black No. 3 for use in cosmetics. Therefore, FDA concludes 
that D&C Black No. 3 prepared in compliance with these measures is safe 
with respect to the potential concern from using cattle materials.
    Toxicity studies provided by the petitioner, including a dermal 
irritation study, an ocular irritation study, a delayed-contact 
hypersensitivity study, and a bioavailability study, demonstrate the 
color additive itself is safe for the proposed cosmetic uses. However, 
the color additive has been shown to contain several impurities in 
trace amounts, including carcinogenic PAHs. To minimize exposure to PAH 
impurities, the agency is setting a limit for total PAHs in D&C Black 
No. 3 of not more than 5 milligrams (mg)/kilogram (kg) (5 parts per 
million). As discussed in the next three paragraphs, the limit for 
total PAHs for D&C Black No. 3 will provide a reasonable certainty that 
no harm will result from the intended use of the color additive.
    Current data have shown that benzo(a)pyrene (B[a]P) is one of the 
most potent carcinogens of the PAH family. To assess the risk from 
exposure to PAHs, FDA used toxic equivalency factors (TEFs) to express 
the comparative toxicity of individual PAHs as fractions of the 
toxicity of B[a]P. This approach expresses the amount of PAHs present 
in terms of B[a]P equivalents and estimates the risk for a mixture of 
PAHs as if it were comprised of one chemical compound. Under this 
methodology, B[a]P was assigned a TEF of 1. In estimating the exposure 
of B[a]P equivalents from the petitioned uses of the color additive, 
FDA normalized the residue levels of the individual PAHs to yield a 
total PAH concentration of approximately 5 mg/kg (the limit for total 
PAHs set by the regulation). Multiplying the normalized residue level 
for each PAH by the TEF for that PAH and summing the results yields a 
B[a]P-equivalent PAH concentration of approximately 1.2 mg/kg. Data 
from a bioavailability study presented in the petition show that B[a]P 
is not absorbed in appreciable amounts from cosmetic matrices (4 
percent to 6 percent absorption) (Refs. 1 and 2). However, as a 
conservative assumption based on the chemical composition of the 
additive, the agency concluded that up to 50 percent of the total PAHs 
were likely to be extracted from the additive under typical use 
conditions, and thus available for absorption by the body (i.e., not 
bound to the cosmetic formulation).
    The agency used data from a carcinogenesis bioassay on B[a]P (Ref. 
3), to estimate the upper-bound limit of lifetime human risk from 
exposure to B[a]P equivalents resulting from the

[[Page 33666]]

petitioned uses of the color additive. This bioassay reported 
treatment-related benign forestomach tumors or esophageal tumors in 
male rats exposed to B[a]P. Using a linear-at-low-dose extrapolation 
method and tumor incidence data from the bioassay, FDA estimated the 
carcinogenic unit risk for B[a]P to be 1.75 (mg/kg body weight/
day)-1. Using this unit risk and an estimated daily exposure 
of 5 x 10-8 mg of B[a]P equivalents/kg body weight/day, FDA 
estimates the upper-bound lifetime human risk from the petitioned uses 
of the color additive to be 8.8 x 10-8 (Ref. 1).
    Because conservative assumptions were used to estimate exposure, an 
individual's actual exposure to PAHs is expected to be substantially 
less than the estimated exposure. The agency concludes that there is 
reasonable certainty that no harm from exposure to PAHs would result 
from the petitioned use of the color additive\1\ (Ref. 4).
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    \1\ FDA also estimated the upper-bound lifetime risk to PAHs 
using the worst-case assumption that PAHs are present at the maximum 
allowable limit of 5 mg/kg, and that all PAHs present have 
carcinogenic potency equivalent to B[a]P. Based on this very 
conservative approach, the upper-bound limit of lifetime human risk 
from the petitioned uses of the additive is 3.7 x 10-7 
(Ref. 1).
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    The agency also considered the potential risk from benzaldehyde, 
benzonitrile, biphenyl, isoquinoline, pyridine and quinoline, which are 
additional impurities produced in trace amounts in the color additive 
from the manufacturing process. The agency concludes that none of these 
substances is present in the color additive at levels that raise any 
safety concerns, and that no specifications are necessary to control 
the amount of these substances as impurities in the color additive 
(Ref. 4).

IV. Conclusions

    Based on data in the petition and other relevant considerations 
discussed previously, FDA concludes that there is a reasonable 
certainty that no harm will result from the petitioned use of D&C Black 
No. 3 as a color additive in eyeliner, eye shadow, mascara, and face 
powder. The agency also concludes that the color additive will achieve 
its intended technical effect, and thus, is suitable for this use. The 
agency further concludes that, in accordance with 21 CFR 71.20(b), 
batch certification of D&C Black No. 3 is necessary to protect the 
public health because of the need to limit the level of PAH impurities, 
some of which have been shown to be carcinogenic. Therefore, 21 CFR 
part 74 should be amended as set forth in this document.

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 will be made 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 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.

VII. 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.

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 Folmer, Division of Petition Review, 
Chemistry Review Team, to Kidwell, Division of Petition Review, July 
6, 2005.
    2. Memorandum from Yourick, Cosmetics Toxicology Branch, 
Division of Cosmetics and Compliance, to Kidwell, Division of 
Petition Review, May 13, 2005.
    3. Brune, H., R.P. Deutsch-Wenzel, M. Habs, et al., 
``Investigation of the Tumorigenic Response to Benzo[a]pyrene in 
Aqueous Caffeine Solution Applied Orally to Sprague-Dawley Rats,'' 
Journal of Cancer Research and Clinical Oncology, 102:153-157, 1981.
    4. Memorandum from Carlson, Division of Petition Review, 
Toxicology Review Group I, to Kidwell, Division of Petition Review, 
February 15, 2006.

List of Subjects in 21 CFR Part 74

    Color additives, Cosmetics, Drugs.

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

PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

0
1. The authority citation for 21 CFR part 74 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 74.2053 is added to subpart C to read as follows:


Sec.  74.2053  D&C Black No. 3.

    (a) Identity. The color additive D&C Black No. 3 is a washed bone 
char prepared from calcined cattle bones. The bones are twice heated in 
excess of 700[deg]C for at least 6 hours.
    (b) Specifications. D&C Black No. 3 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 
current good manufacturing practices:

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    (1) Calcium hydroxyapatite (CaO and P2O5), 
not less than 75 percent and not more than 84 percent;
    (2) Elemental carbon, not less than 7 percent;
    (3) Moisture, not more than 7 percent;
    (4) Silica (SiO2), not more than 5 percent;
    (5) Arsenic, not more than 3 milligrams (mg)/kilogram (kg) (3 parts 
per million (ppm));
    (6) Lead, not more than 10 mg/kg (10 ppm); and
    (7) Total polycyclic aromatic hydrocarbons (PAHs), not more than 5 
mg/kg (5 ppm).
    (c) Uses and restrictions. Cosmetics containing D&C Black No. 3 
must comply with Sec.  700.27 of this chapter with respect to 
prohibited cattle materials in cosmetic products. D&C Black No. 3 may 
be safely used for coloring the following cosmetics in amounts 
consistent with current good manufacturing practice: Eyeliner, eye 
shadow, mascara, and face powder.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Black No. 3 shall be 
certified in accordance with regulations in part 80 of this chapter.

    Dated: June 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11801 Filed 6-18-07; 8:45 am]
BILLING CODE 4160-01-S