See also February 24, 2006 Federal Register Notice
[Federal Register: July 26, 2005 (Volume 70, Number 142)]
[Rules and Regulations]
[Page 43043-43045]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy05-11]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. 2001C-0486] (formerly Docket No. 01C-0486)
Listing of Color Additives Exempt From Certification; Tomato
Lycopene Extract and Tomato Lycopene Concentrate
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 tomato lycopene
extract and tomato lycopene concentrate as color additives in foods.
This action is in response to a petition filed by LycoRed Natural
Products Industries.
DATES: This rule is effective August 26, 2005; except as to any
provisions that may be stayed by the filing of proper objections.
Submit written or electronic objections and requests for a hearing by
August 25, 2005. See section VIII of this document for information on
the filing of objections. The Director of the Office of the Federal
Register approves the incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51 of a certain publication in new 21 CFR
73.585 effective August 26, 2005.
[[Page 43044]]
ADDRESSES: You may submit written or electronic objections and requests
for a hearing, identified by Docket No. 2001C-0486, by any of the
following methods:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
<bullet> Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
<bullet> E-mail: fdadockets@oc.fda.gov. Include Docket No. 2001C-
0486 in the subject line of your e-mail message.
<bullet> 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 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
comments 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: James C. Wallwork, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1303.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of October 30, 2001
(66 FR 54773), FDA announced that a color additive petition (CAP
1C0273) had been filed by LycoRed Natural Products Industries, c/o TC
Associates, Inc., P.O. Box 285, West Boxford, MA 01885 (current
address, c/o Mark R. Kaster, suite 1500, 50 South Sixth St.,
Minneapolis, Minnesota 55402-1498). The petition proposed to amend the
color additive regulations in part 73 (21 CFR part 73) to provide for
the safe use of tomato lycopene extract to color foods generally. The
petition included information on two forms of tomato lycopene extract
that differ primarily in concentration. The agency is listing the less
concentrated form as tomato lycopene extract and the more concentrated
form as tomato lycopene concentrate.
II. Identity and Manufacturing
Tomato lycopene extract is a red to dark brown viscous oleoresin
containing lycopene. Lycopene is the pigment responsible for the red
color of tomatoes. Tomato lycopene extract is manufactured as follows:
(1) Fresh, edible varieties of tomatoes are crushed and heated at 70 to
120[deg] C, and then centrifuged to separate the pulp from the liquid
portion; (2) the tomato pulp is extracted with ethyl acetate; and (3)
ethyl acetate is evaporated from the extracts, resulting in tomato
lycopene extract. Tomato lycopene extract manufactured by the
petitioner contains not less than 5.5 percent lycopene, which comprises
not less than 70 percent of total carotenoids. Tomato lycopene
concentrate is a mixture of crystalline and amorphous powder prepared
from tomato lycopene extract by removing most of the tomato lipids with
ethyl acetate followed by evaporating the solvent. Tomato lycopene
concentrate manufactured by the petitioner contains not less than 60
percent lycopene.
III. Safety Evaluation
Lycopene is a commonly consumed food ingredient present in fresh
tomatoes and in tomato-containing foods. The intake of lycopene from
the petitioned use of the color additives in foods is similar to that
from the consumption of tomatoes and tomato-containing foods. The
agency reviewed the results of toxicological studies submitted in the
petition. Based on this review, the agency concludes that there was no
treatment-related toxicity from lycopene. The agency also conducted a
comprehensive literature search that found no evidence of any
significant toxicological effects of lycopene when consumed by humans.
To further assure the purity and safety of the subject color additives,
the agency is specifying in new Sec. 73.585 that tomato lycopene
extract be obtained from fresh, edible varieties of tomato and is
establishing specifications for both color additives.
IV. Conclusion
Based on the data in the petition and other relevant material, FDA
concludes the following: (1) The petitioned use of tomato lycopene
extract and tomato lycopene concentrate as color additives in foods is
safe, (2) the additives will achieve their intended technical effects,
and thus, (3) the additives are suitable for this use. The agency
concludes that 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 tomato lycopene
extract and tomato lycopene concentrate is not necessary for the
protection of the public health.
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 (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 previously considered the environmental effects of
this rule as announced in the notice of filing for CAP 1C0273 (66 FR
54773, October 30, 2001). No new information or comments have been
received that would affect the agency's previous determination that
there is no significant impact on the human environment and that an
environmental impact statement is not required.
VII. Paperwork Reduction Act of 1995
This final rule contains no collections 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
[[Page 43045]]
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.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Incorporation by reference,
Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 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 73.585 is added to subpart A to read as follows:
Sec. 73.585 Tomato lycopene extract; tomato lycopene concentrate.
(a) Identity. (1) The color additive tomato lycopene extract is a
red to dark brown viscous oleoresin extracted with ethyl acetate from
tomato pulp followed by removal of the solvent by evaporation. The pulp
is produced from fresh, edible varieties of the tomato by removing the
liquid. The main coloring component is lycopene.
(2) The color additive tomato lycopene concentrate is a powder
prepared from tomato lycopene extract by removing most of the tomato
lipids with ethyl acetate and then evaporating off the solvent.
(3) Color additive mixtures made with tomato lycopene extract or
tomato lycopene concentrate may contain only those diluents listed in
this subpart as safe and suitable for use in color additive mixtures
for coloring food.
(b) Specifications. (1) Tomato lycopene extract shall conform to
the following specification: Lycopene, not less than 5.5 percent of
oleoresin as determined by the method entitled ``Qualitative Analysis
of Lycopene, Its Isomers and Other Carotenoids in Different
Concentrations of Lyc-O-Mato[reg] (Tomato Oleoresin) and in Tomato Pulp
by High Performance Liquid Chromatography (HPLC),'' S.O.P. number :
Lab/119/01, Revision 01, dated May 30, 2001, published by LycoRed
Natural Products Industries, which is incorporated by reference, or an
equivalent method. The Director of the Office of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain a copy of the method from the
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. You
may inspect a copy at the Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD, or at
the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
(2) Tomato lycopene concentrate shall conform to the following
specification: Lycopene, not less than 60 percent of oleoresin as
determined by the method identified in paragraph (b)(1) of this
section.
(c) Uses and restrictions. Tomato lycopene extract and tomato
lycopene concentrate may be safely used for coloring foods generally in
amounts consistent with good manufacturing practice, except that they
may not be used to color foods for which standards of identity have
been issued under section 401 of the act, unless the use of added color
is authorized by such standards.
(d) Labeling. The label of the color additive shall conform to the
requirements of Sec. 70.25 of this chapter.
(e) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health, and
therefore batches thereof are exempt from the certification
requirements of section 721(c) of the act.
Dated: July 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14631 Filed 7-25-05; 8:45 am]
BILLING CODE 4160-01-S