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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2019]
[CITE: 21CFR178.3780]



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 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

Subpart D--Certain Adjuvants and Production Aids

Sec. 178.3780 Polyhydric alcohol esters of long chain monobasic acids.

Polyhydric alcohol esters of long chain monobasic acids identified in this section may be safely used as lubricants in the fabrication of polyvinyl chloride and/or polyvinyl chloride copolymer articles complying with 177.1980 of this chapter that contact food of Types I, II, IV-B, VI-B, VII-B, and VIII identified in table 1 in 176.170(c) of this chapter under conditions of use E, F, and G described in table 2 in 176.170(c) of this chapter, subject to the provisions of this section.

(a) Identity. For the purpose of this section, polyhydric alcohol esters of long chain monobasic acids consist of polyhydric alcohol esters having number average molecular weights in the range of 1,050 to 1,700. The esters are produced by the reaction of either ethylene glycol or glycerol with long chain monobasic acids containing from 9 to 49 carbon atoms obtained by the ozonization of long chain alpha -olefins, the unreacted carboxylic acids in the formation of the glycerol esters being neutralized with calcium hydroxide to produce a composition having up to 2 percent by weight calcium. The alpha -olefins, obtained from the polymerization of ethylene, have 20 to 50 carbon atoms and contain a minimum of 75 percent by weight straight chain alpha -olefins and not more than 25 percent vinylidene compounds.

(b) Specifications. The polyhydric alcohol esters have the following specifications:

(1) Melting point of 60-80 deg. C for the ethylene glycol ester and 90-105 deg. C for the glycerol ester as determined by the Fisher Johns method as described in "Semimicro Qualitative Organic Analysis--The Systematic Identification of Organic Compounds," by Cheronis and Entrikin, 2d Ed., Interscience Publishers, NY, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

(2) Acid value 15-25 for each ester as determined by the A.O.C.S. method Trla-64T "Titer Test," which is incorporated by reference. Copies are available from American Association of Oil Chemists, 36 East Wacker Drive, Chicago, IL 60601, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html. The method is modified to use as the acid solvent a 1:1 volume mixture of anhydrous isopropyl alcohol and toluene. The solution is titrated with 0.1N methanolic sodium hydroxide.

(3) Saponification value 120-160 for the ethylene glycol ester and 90-130 for the glycerol ester as determined the A.O.C.S. method Trla-64T "Saponification Value," which is incorporated by reference. Copies are available from American Association of Oil Chemists, 36 East Wacker Drive, Chicago, IL 60601, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

(4) Ultraviolet absorbance as specified in 178.3770(a)(4) of this chapter when tested by the analytical method described therein.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 54 FR 24899, June 12, 1989; 61 FR 14481, Apr. 2, 1996]

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