[Federal Register Volume 69, Number 144 (Wednesday, July 28, 2004)]
[Rules and Regulations]
[Pages 44927-44930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17153]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. 1987C-0023]


Listing of Color Additives Subject to Certification; D&C Black 
No. 2

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. 2 (a 
high-purity furnace black, subject to FDA batch certification) as a 
color additive in the following cosmetics: Eyeliner, brush-on-brow, eye 
shadow, mascara, lipstick, blushers and rouge, makeup and foundation, 
and nail enamel. This action is in response to a petition filed by the 
Cosmetic, Toiletry, and Fragrance Association.

DATES: This rule is effective August 30, 2004. Submit objections and 
requests for a hearing by August 27, 2004. See

[[Page 44928]]

section VIII of this document for information on the filing of 
objections.

ADDRESSES: Submit written objections and requests for a hearing to the 
Division of Dockets Management (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: Celeste Johnston, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 202-418-3423.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of March 13, 1987 (52 
FR 7933), FDA announced that a color additive petition (CAP 7C0208) had 
been filed by the Cosmetic, Toiletry, and Fragrance Association, Inc., 
1110 Vermont Ave. NW., Washington, DC 20005 (current address, 1101 17th 
St. NW., suite 300, Washington, DC 20036-4702). The petition proposed 
to amend the color additive regulations in part 74 (21 CFR part 74, 
subpart C) to provide for the safe use of carbon black as a color 
additive for coloring cosmetics generally, including cosmetics for use 
in the area of the eye. The petitioner has now limited its proposed use 
of carbon black to the following cosmetics: Eyeliner, brush-on-brow, 
eye shadow, mascara, lipstick, blushers and rouge, makeup and 
foundation, and nail enamel. During its review of the petition, the 
agency determined that the subject carbon black is a fine-particle 
high-purity furnace black that 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. 2. Therefore, this color additive will 
be identified as D&C Black No. 2.
    The petitioner has requested the use of D&C Black No. 2 in 
cosmetics, including 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 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.''
    The regulation in 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. 2 is a high-purity carbon black prepared by the oil 
furnace process. It is manufactured by injecting a heated aromatic 
petroleum oil feedstock into the combustion zone of a natural gas fired 
furnace. The reaction is quenched with water and the carbon particles 
are further cooled and collected on a fabric filter. The high-purity 
furnace black that is the subject color additive of this rule consists 
essentially of pure carbon, formed as aggregated fine particles with a 
surface area range of 200 to 260 meters\2\/gram.
    As explained under III.B of this document, the color additive D&C 
Black No. 2 may contain low levels of potentially carcinogenic 
polynuclear aromatic hydrocarbon (PAH) contaminants. To limit the 
amounts of these contaminants in the color additive, FDA is requiring 
that D&C Black No. 2 for use in cosmetics be from a batch of the color 
additive certified by FDA, and is setting specifications for total 
PAHs, benzo[a]pyrene (B[a]P), and dibenz[a,h]anthracene. Because any 
PAH contaminants in the color additive can tightly bind to the carbon 
particles, the bioavailability of PAHs will be inversely related to the 
surface area of the carbon particles. Therefore, the agency is setting 
a specification for surface area, determined by the nitrogen Brunauer, 
Emmett, Teller (BET) method.
    In general, the surface area of the carbon particles is also 
inversely related to their particle size. Because eye irritation may be 
caused by larger carbon particles, a specification for surface area by 
nitrogen BET will also limit the size of the carbon particles to those 
fine enough to ensure eye area safety.
    To limit the amounts of heavy metals in the color additive, which 
substances may be derived from the manufacturing process water and the 
feedstock, the agency is also setting specifications for arsenic, lead, 
and mercury.
    For a certifiable color additive, the sum of total color plus the 
levels of appropriate impurities should approximate 100 percent, 
allowing mass accountability. The total color from D&C Black No. 2 
comes from the elemental carbon itself. The levels of appropriate 
impurities can be obtained from data for ash, volatile matter, and 
total sulfur. Therefore, the agency is setting specifications for total 
color (as carbon), ash content, weight loss on heating, and total 
sulfur.

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 so-called ``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 or Delaney clause of the color additive amendments 
(section 721(b)(5)(B) of the act) 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

    D&C Black No. 2 is inert. Its insolubility and lack of toxicity, 
coupled with a history of safe use of activated carbon in medicine, 
contribute to the agency's conclusion that the color additive itself is 
safe for its proposed uses. However, the color additive has been shown 
to contain low levels of PAH impurities, some of which are 
carcinogenic. To minimize exposure to contaminants, the agency is 
setting

[[Page 44929]]

limits for the following PAHs as a proportion of D&C Black No. 2: total 
PAHs (0.5 milligram (mg)/kilogram (kg)); B[a]P (0.005 mg/kg); and 
dibenz[a,h]anthracene (0.005 mg/kg).
    Current data have shown B[a]P to be one of the most potent 
carcinogens of the PAH family. To assess the risk from exposure to 
PAHs, FDA has used toxic equivalency factors to express the comparative 
toxicity of 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 one chemical 
compound. Under this system, B[a]P has been assigned a B[a]P toxic 
equivalency of 1. FDA has estimated the exposure to B[a]P equivalents 
from the use of high-purity furnace black in cosmetics to be no greater 
than 7.2 x 10-10 mg/kg body weight/day (Ref. 1). In 
estimating the exposure to B[a]P equivalents from the petitioned use of 
the color additive, FDA assumed that both B[a]P and 
dibenz[a,h]anthracene were present at their proposed limits of 0.005 
mg/kg and that each of the other possible PAH contaminants would be 
present in equal amounts, with a total PAH concentration of 0.5 mg/kg 
(Ref. 1). Based on the evidence presented in the petition, the agency 
also concluded that no more than 10 percent of the total PAHs present 
were likely to be extractable from the additive under typical use 
conditions, and thus available for absorption by the body (Refs. 2 and 
3).
    The agency used data from a carcinogenesis bioassay on B[a]P, 
conducted by H. Brune, et al., to estimate the upper-bound limit of 
lifetime human risk from exposure to B[a]P equivalents resulting from 
the petitioned use of the color additive (Ref. 4). The authors 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 H. Brune, et al. study, the 
FDA estimated the carcinogenic unit risk for B[a]P to be 1.75 (mg/kg 
body weight/day)-1. Using this carcinogenic risk for B[a]P 
and an estimated daily exposure of 7.2 x10-10 mg of B[a]P 
equivalents/kg body weight/day, FDA estimates that the upper-bound 
limit of lifetime human risk from the petitioned use of the additive is 
1.3 x 10-9, or less than 1 in 1 billion (Refs. 1 and 5 
through 7).
    Because conservative assumptions were used to estimate exposure, 
and PAHs bind tightly to carbon black and are not expected to be 
bioavailable, the average individual exposure to B[a]P toxic 
equivalents is expected to be substantially less than the estimated 
exposure (Refs. 5 and 6). The actual risk will likely be less than the 
calculated upper-bound limit of risk. Thus, the agency concludes that 
there is reasonable certainty that no harm from exposure to PAHs would 
result from the petitioned use of the additive.\1\
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    \1\ FDA has also estimated the upper-bound limit of lifetime 
human risk to PAHs using the worst-case assumption that all PAHs in 
the additive have the same carcinogenic potency as B[a]P. Based on 
this highly conservative approach, FDA estimates that the upper-
bound limit of lifetime human risk from the petitioned use of the 
additive is 1.5 x 10-8, or about 1 in 100 million (Ref. 
6).
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    In addition, no toxicity was noted in studies provided by the 
petitioner to support the safety of D&C Black No. 2 to color cosmetics 
intended for use in the area of the eye (Ref. 8).

IV. Conclusions

    Based on the data in the petition and other relevant considerations 
discussed in section III of this document, FDA concludes that there is 
a reasonable certainty that no harm will result from the petitioned use 
of D&C Black No. 2 as a color additive in the following cosmetics: 
Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and 
rouge, makeup and foundation, and nail enamel. 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. 2 is necessary to protect the public health because of 
the need to limit the levels of PAHs, some of which have been shown to 
be carcinogenic. Therefore, 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 are available for inspection at the Center for 
Food Safety and Applied Nutrition by appointment with the information 
contact person listed (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. 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, Division of Product Manufacture and 
Use, to White, Division of Petition Control, March 23, 1998.
    2. Memorandum from Cramer, Food and Color Additives Review 
Section, to Kashtok, Direct Additive Branch, July 25, 1990.
    3. Memorandum from Folmer, Division of Petition Review Chemistry 
Review Group, to Johnston, Division of Petition Review, September 
30, 2003.
    4. Brune, H., R. P. Deutsch-Wenzel, M. Habs, S. Ivankovis, and 
D. Schmahl, ``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.
    5. Memorandum from Carlson, Division of Petition Review, to 
Peiperl, Division of Petition Review, July 2, 2003.
    6. Memorandum from Kraeling, Cosmetic Toxicology Branch, to 
Peiperl, Division of Petition Control, April 22, 2003.
    7. Memorandum from Folmer, Division of Petition Review Chemistry 
Review Group, to Peiperl, Division of Petition Review, July 1, 2003.
    8. Memorandum from Kraeling, Office of Cosmetics and Colors, to 
Peiperl, Division of Petition Review, July 15, 1999.

VIII. Objections

    Any person who will be adversely affected by this regulation may at 
any time 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

[[Page 44930]]

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.

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 74.2052 is added to subpart C to read as follows:


Sec.  74.2052  D&C Black No. 2.

    (a) Identity. The color additive D&C Black No. 2 is a high-purity 
carbon black prepared by the oil furnace process. It is manufactured by 
the combustion of aromatic petroleum oil feedstock and consists 
essentially of pure carbon, formed as aggregated fine particles with a 
surface area range of 200 to 260 meters (m)\2\/gram.
    (b) Specifications. D&C Black No. 2 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) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 
200 to 260 m\2\/gram.
    (2) Weight loss on heating at 950 [deg]C for 7 minutes (predried 
for 1 hour at 125 [deg]C), not more than 2 percent.
    (3) Ash content, not more than 0.15 percent.
    (4) Arsenic (total), not more than 3 milligrams per kilogram (mg/
kg) (3 parts per million).
    (5) Lead (total), not more than 10 mg/kg (10 parts per million).
    (6) Mercury (total), not more than 1 mg/kg (1 part per million).
    (7) Total sulfur, not more than 0.65 percent.
    (8) Total PAHs, not more than 0.5 mg/kg (500 parts per billion).
    (9) Benzo[e]pyrene, not more than 0.005 mg/kg (5 parts per 
billion).
    (10) Dibenz[a,h]anthracene, not more than 0.005 mg/kg (5 parts per 
billion).
    (11) Total color (as carbon), not less than 95 percent.
    (c) Uses and restrictions. D&C Black No. 2 may be safely used for 
coloring the following cosmetics in amounts consistent with current 
good manufacturing practice: Eyeliner, brush-on-brow, eye shadow, 
mascara, lipstick, blushers and rouge, makeup and foundation, and nail 
enamel.
    (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. 2 shall be 
certified in accordance with regulations in part 80 of this chapter.

    Dated: July 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-17153 Filed 7-27-04; 8:45 am]
BILLING CODE 4160-01-S