[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1660]
[Page 317]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177 INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1660 Poly (tetramethylene terephthalate).
Poly(tetramethylene terephthalate) (poly (oxytetramethyleneoxyter-
ephthaloyl)) [Chemical Abstracts Service Registry No. 24968.12-5]
identified in this section may be safely used as articles or components
of articles intended to contact food, in accordance with the following
prescribed conditions:
(a) Identity. For the purpose of this section, poly (tetramethylene
terephthalate) is the reaction product of dimethyl terephthalate with
1,4-butanediol to which may have been added certain optional substances
to impart desired technological properties to the polymer.
(b) Optional adjuvant substances. Poly(tetramethylene terephthalate)
identified in paragraph (a) of this section may contain optional
adjuvant substances. The quantity of any optional adjuvant substance
employed in the production of the polymer does not exceed the amount
reasonably required to accomplish the intended technical or physical
effect. Such adjuvants may include substances generally recognized as
safe in food, substances used in accordance with prior sanction, and
substances permitted under applicable regulations in this part.
(c) Specifications. (1) Inherent viscosity of a 0.50 percent
solution of the polymer in phenol/tetrachloroethane (60/40 weight ratio)
solvent is not less than 0.6 as determined using a Wagner viscometer (or
equivalent) and calculated from the following equation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.400
where:
Nr=Ratio of flow time of the polymer solution to that of the solvent and
c=polymer concentration of the test solution in grams per 100
milliliters.
(2) Poly(tetramethylene terephthalate) in the finished form in which
it is to contact food shall yield total extractives as follows:
(i) Not to exceed 0.08 milligram per square inch of food contact
surface when extracted for 2 hours at 250 [deg]F with distilled water.
(ii) Not to exceed 0.02 milligram per square inch of food contact
surface when extracted for 2 hours at 150 [deg]F with n-heptane.
(iii) Not to exceed 0.04 milligram per square inch of food contact
surface when extracted for 2 hours at 212 [deg]F with 3 percent aqueous
acetic acid.
(iv) Not to exceed 0.02 milligram per square inch of food contact
surface when extracted for 2 hours at 65.6 [deg]C (150 [deg]F) with 50
percent ethanol.
[42 FR 14572, Mar. 15, 1977, as amended at 50 FR 20748, May 20, 1985; 52
FR 20069, May 29, 1987]
Back to Top
© 2007 Betterchem Corp.
|
