[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