Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2008]
[CITE: 21CFR172.215]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart C--Coatings, Films and Related Substances
Sec. 172.215 Coumarone-indene resin.

The food additive coumarone-indene resin may be safely used on grapefruit, lemons, limes, oranges, tangelos, and tangerines in accordance with the following prescribed conditions:

(a) The food additive is manufactured by the polymerization of a crude, heavy coal-tar solvent naphtha meeting the following specifications:

(1) It is a mixture of indene, indan (hydrindene), substituted benzenes, and related compounds.

(2) It contains no more than 0.25 percent tar bases.

(3) 95 percent distills in the range 167 deg. C-184 deg. C.

(b) The food additive meets the following specifications:

(1) Softening point, ring and ball: 126 deg. C minimum as determined by ASTM method E28-67 (Reapproved 1982), "Standard Test Method for Softening Point by Ring-and-Ball Apparatus," which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined 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) Refractive index (n 25/D ) 1.63-1.64.

(c) It is used or intended for use as a protective coating for grapefruit, lemons, limes, oranges, tangelos, and tangerines whereby the maximum amount of the resin remaining on the fruit does not exceed 200 parts per million on a fresh-weight basis.

(d) To assure safe use of the additive:

(1) The label of the market package or any intermediate premix of the additive shall bear, in addition to the other information required by the act:

(i) The name of the additive, coumarone-indene resin.

(ii) A statement of the concentration of the additive therein.

(2) The label or accompanying labeling shall bear adequate directions that, if followed, will result in a finished food not in conflict with the requirements of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10103, Mar. 19, 1984]

Database Updated April 1, 2008

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH