[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table
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
(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/
(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.
[70 FR 43045, July 26, 2005]
Additives that reference this regulation: