[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: 21CFR177.1970]
[Page 327-328]
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. 177.1970 Vinyl chloride-lauryl vinyl ether copolymers.
The vinyl chloride-lauryl vinyl ether copolymers identified in
paragraph (a) of this section may be used as an article or as a
component of an article intended for use in contact with food subject to
the provisions of this section.
(a) Identity. For the purposes of this section vinyl chloride-lauryl
vinyl ether copolymers consist of basic copolymers produced by the
copolymerization of vinyl chloride and lauryl vinyl ether such that the
finished copolymers contain not more than 3 weight-percent of polymer
units derived from lauryl vinyl ether and meet the specifications and
extractives limitations prescribed in paragraph (c) of this section.
(b) Optional adjuvant substances. The basic vinyl chloride-lauryl
vinyl ether copolymers identified in paragraph (a) of this section may
contain optional adjuvant substances required in the production of such
basic copolymers. These optional adjuvant substances may include
substances permitted for such use by regulations in parts 170 through
189 of this chapter, substances generally recognized as safe in food,
and substances used in accordance with a prior sanction or approval.
(c) Specifications and limitations. The vinyl chloride-lauryl vinyl
ether basic copolymers meet the following specifications and extractives
limitations:
(1) Specifications. (i) Total chlorine content is 53 to 56 percent
as determined by any suitable analytical procedure of generally accepted
applicability.
(ii) Inherent viscosity in cylcoHhexanone at 30 [deg]C is not less
than 0.60 deciliter per gram as determined by ASTM method D1243-79,
``Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride
Polymers,'' 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) Extractives limitations. The following extractives limitations
are determined by the method described in paragraph (d) of this section:
(i) Total extractives do not exceed 0.03 weight-percent when
extracted with water at 150 [deg]F for 2 hours.
(ii) Total extractives do not exceed 0.60 weight-percent when
extracted with n-heptane at 150 [deg]F for 2 hours.
(d) Analytical methods. The analytical methods for determining total
extractives are applicable to the basic copolymers in powder form having
a particle size such that 100 percent will pass through a U.S. Standard
Sieve No. 40 and such that not more than 10 percent will pass through a
U.S. Standard Sieve No. 200.
(1) Reagents--(i) Water. All water used in these procedures shall be
demineralized (deionized), freshly distilled water.
(ii) n-Heptane. Reagent grade, freshly distilled n-heptane shall be
used.
(2) Determination of total amount of extractives. Place an
accurately weighed sample of suitable size in a clean borosilicate
flask, and for each gram of sample add 3 milliliters of solvent
previously heated to 150 [deg]F. Maintain the temperature of the
contents of the flask at 150 [deg]F for 2 hours using a hot plate while
also maintaining gentle mechanical agitation. Filter the contents of the
flask rapidly through No. 42 Whatman filter paper with the aid of
suction. Transfer the filtrate to flat glass dishes that are warmed on a
hot plate and evaporate the solvent with the aid of a stream of filtered
air. When the volume of the filtrate has been reduced to 10 to 15
milliliters, transfer the filtrate to tared 50-milliliter borosilicate
glass beakers and complete evaporation to a constant weight in a 140
[deg]F vacuum oven. Carry out a corresponding blank determination with
each solvent. Determine the weight of the residue corrected for the
[[Page 328]]
solvent blank and calculate the result as percent of the initial weight
of the resin sample taken for analysis.
(e) Other specifications and limitations. The vinyl chloride-lauryl
vinyl ether copolymers identified in and complying with this section,
when used as components of the food-contact surface of any article that
is subject to a regulation in parts 174, 175, 176, 177, 178 and Sec.
179.45 of this chapter, shall comply with any specifications and
limitations prescribed by such regulation for the article in the
finished form in which it is to contact food.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984]
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