Listing of Color Additives Exempt From Certification; Tomato Lycopene Extract and Tomato Lycopene Concentrate, 43043-43045 [05-14631]
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Federal Register / Vol. 70, No. 142 / Tuesday, July 26, 2005 / Rules and Regulations
7430(e); 18 U.S.C. 2510 et seq.; 22 U.S.C.
287c, 22 U.S.C. 3201 et seq., 22 U.S.C. 6004;
30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app.
466c; 50 U.S.C. app. 5; Sec. 901–911, Pub. L.
106–387; Sec. 221, Pub. L. 107–56; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001
Comp., p. 783; Notice of August 6, 2004, 69
FR 48763, 3 CFR, 2004 Comp., p. 284.
SUPPLEMENT NO. 1 TO PART 774—
[AMENDED]
a.4. Equipment, having a maximum digital
interface transfer rate exceeding 175 Mbit/s,
designed to convert digital video magnetic
tape recorders for use as digital
instrumentation data recorders;
a.5. Waveform digitizers and transient
recorders having all of the following: N.B.:
See also 3A292.
a.5.a. Digitizing rates equal to or more than
200 million samples per second and a
resolution of 10 bits or more; and
a.5.b. A continuous throughput of 2 Gbit/
s or more;
2. In Supplement No. 1 to Part 774 (the
Commerce Control List), Category 3—
Electronics, Export Control
Classification Number (ECCN) 3A002 is
amended by revising the ‘‘items’’
paragraph of the List of Items Controlled
section, to read as follows:
Technical Note: For those instruments
with a parallel bus architecture, the
continuous throughput rate is the highest
word rate multiplied by the number of bits
in a word. Continuous throughput is the
fastest data rate the instrument can output to
mass storage without the loss of any
information while sustaining the sampling
rate and analog-to-digital conversion.
I
3A002 General purpose electronic
equipment, as follows (see List of Items
Controlled).
*
*
*
*
*
List of Items Controlled
Unit: * * *
Related Controls: * * *
Related Definitions: * * *
Items:
a. Recording equipment, as follows, and
specially designed test tape therefor:
a.1. Analog instrumentation magnetic tape
recorders, including those permitting the
recording of digital signals (e.g., using a high
density digital recording (HDDR) module),
having any of the following:
a.1.a. A bandwidth exceeding 4 MHz per
electronic channel or track;
a.1.b. A bandwidth exceeding 2 MHz per
electronic channel or track and having more
than 42 tracks; or
a.1.c. A time displacement (base) error,
measured in accordance with applicable IRIG
or EIA documents, of less than ‘‘0.1 :s;
Note: Analog magnetic tape recorders
specially designed for civilian video
purposes are not considered to be
instrumentation tape recorders.
a.2. Digital video magnetic tape recorders
having a maximum digital interface transfer
rate exceeding 360 Mbit/s;
Note: 3A002.a.2 does not control digital
video magnetic tape recorders specially
designed for television recording using a
signal format, which may include a
compressed signal format, standardized or
recommended by the ITU, the IEC, the
SMPTE, the EBU, the ETSI, or the IEEE for
civil television applications.
a.3. Digital instrumentation magnetic tape
data recorders employing helical scan
techniques or fixed head techniques, having
any of the following:
a.3.a. A maximum digital interface transfer
rate exceeding 175 Mbit/s; or
a.3.b. Being ‘‘space qualified’’;
Note: 3A002.a.3 does not control analog
magnetic tape recorders equipped with
HDDR conversion electronics and configured
to record only digital data.
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a.6. Digital instrumentation data recorders,
using magnetic disk storage technique,
having all of the following:
a.6.a. Digitizing rate equal to or more than
100 million samples per second and a
resolution of 8 bits or more; and
a.6.b. A continuous throughput of 1 Gbit/
s or more;
b. ‘‘Frequency synthesizer’’ ‘‘electronic
assemblies’’ having a ‘‘frequency switching
time’’ from one selected frequency to another
of less than 1 ms;
c. Radio frequency ‘‘signal analyzers’’, as
follows:
c.1. ‘‘Signal analyzers’’ capable of
analyzing any frequencies exceeding 31.8
GHz but not exceeding 37.5 Ghz and having
a 3 dB resolution bandwidth (RBW)
exceeding 10 MHz;
c.2. ‘‘Signal analyzers’’ capable of
analyzing frequencies exceeding 43.5 Ghz;
c.3. ‘‘Dynamic signal analyzers’’ having a
‘‘real-time bandwidth’’ exceeding 500 kHz;
Note: 3A002.c.3 does not control those
‘‘dynamic signal analyzers’’ using only
constant percentage bandwidth filters (also
known as octave or fractional octave filters).
d. Frequency synthesized signal generators
producing output frequencies, the accuracy
and short term and long term stability of
which are controlled, derived from or
disciplined by the internal master frequency,
and having any of the following:
d.1. A maximum synthesized frequency
exceeding 31.8 GHz, but not exceeding 43.5
GHz and rated to generate a pulse duration
of less than 100 ns;
d.2. A maximum synthesized frequency
exceeding 43.5 GHz;
d.3. A ‘‘frequency switching time’’ from
one selected frequency to another of less than
1 ms; or
d.4. A single sideband (SSB) phase noise
better than –(126 + 20 log10F¥20 log10f) in
dBc/Hz, where F is the off-set from the
operating frequency in Hz and f is the
operating frequency in MHz;
Technical Note: For the purposes of
3A002.d.1., ‘pulse duration’ is defined as the
time interval between the leading edge of the
pulse achieving 90% of the peak and the
trailing edge of the pulse achieving 10% of
the peak.
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43043
Note: 3A002.d does not control equipment
in which the output frequency is either
produced by the addition or subtraction of
two or more crystal oscillator frequencies, or
by an addition or subtraction followed by a
multiplication of the result.
e. Network analyzers with a maximum
operating frequency exceeding 43.5 GHz;
f. Microwave test receivers having all of the
following:
f.1. A maximum operating frequency
exceeding 43.5 GHz; and
f.2. Being capable of measuring amplitude
and phase simultaneously;
g. Atomic frequency standards having any
of the following:
g.1. Long-term stability (aging) less (better)
than 1 × 10–11/month; or
g.2. Being ‘‘space qualified’’.
Note: 3A002.g.1 does not control non‘‘space qualified’’ rubidium standards.
Dated: July 21, 2005.
Eileen Albanese,
Director, Office of Exporter Services.
[FR Doc. 05–14745 Filed 7–25–05; 8:45 am]
BILLING CODE 3510–33–P
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.
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.
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43044
Federal Register / Vol. 70, No. 142 / Tuesday, July 26, 2005 / Rules and Regulations
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: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
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 https://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 https://
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:
ADDRESSES:
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
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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° 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 tomatocontaining 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 § 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
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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 § 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 § 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 § 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
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Federal Register / Vol. 70, No. 142 / Tuesday, July 26, 2005 / Rules and Regulations
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.
I 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
1. The authority citation for 21 CFR
part 73 continues to read as follows:
I
Authority: 21 U.S.C. 321, 341, 342, 343,
348, 351, 352, 355, 361, 362, 371, 379e.
2. Section 73.585 is added to subpart
A to read as follows:
I
§ 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
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Jkt 205001
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-OMato (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: https://www.archives.gov/
federallregister/
codeloflfederallregulations/
ibrllocations.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 § 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
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43045
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Tiamulin Liquid Concentrate
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by
Phoenix Scientific, Inc. The ANADA
provides for use of tiamulin concentrate
solution to prepare medicated drinking
water for the treatment of swine
dysentery and swine pneumonia.
DATES: This rule is effective July 26,
2005.
FOR FURTHER INFORMATION CONTACT:
Daniel A. Benz, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.gov.
SUPPLEMENTARY INFORMATION: Phoenix
Scientific, Inc., 3915 South 48th Street
Ter., St. Joseph, MO 64503, filed
ANADA 200–360 that provides for use
of Tiamulin Liquid Concentrate to
prepare medicated drinking water for
the treatment of swine dysentery and
swine pneumonia. Phoenix Scientific,
Inc.’s Tiamulin Liquid Concentrate is
approved as a generic copy of
Boehringer Ingelheim Vetmedica, Inc.’s
DENAGARD (tiamulin) Liquid
Concentrate approved under NADA
140–916. The ANADA is approved as of
June 24, 2005, and the regulations are
amended in § 520.2456 (21 CFR
520.2456) to reflect the approval. The
basis of approval is discussed in the
freedom of information summary.
The regulations are also amended in
§ 520.2456 to reflect a more recent genus
name for the causative pathogen for
swine dysentery. This action is being
taken to improve the accuracy of the
regulations.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
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]]>Agencies
[Federal Register Volume 70, Number 142 (Tuesday, July 26, 2005)]
[Rules and Regulations]
[Pages 43043-43045]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14631]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://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 https://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 https://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: https://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
