[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:
     Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting comments on the agency Web site.
     E-mail: fdadockets@oc.fda.gov. Include Docket No. 2001C-
0486 in the subject line of your e-mail message.
     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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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