[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: 21CFR177.1240]
[Page 256]
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. 177.1240 1,4-Cyclohexylene dimethylene terephthalate and
1,4-cyclohexylene dimethylene isophthalate copolymer.
Copolymer of 1,4-cyclohexylene dimethylene terephthalate and 1,4-
cyclohexylene dimethylene iso phtha late may be safely used as an
article or component of articles used in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food, subject to the provisions of this section:
(a) The copolymer is a basic polyester produced by the catalytic
condensation of dimethyl terephthalate and dimethyl isophthalate with
1,4-cyclohexanedimethanol, to which may have been added certain optional
substances required in its production or added to impart desired
physical and technical properties.
(b) The quantity of any optional substance employed in the
production of the copolymer does not exceed the amount reasonably
required to accomplish the intended physical or technical effect or any
limitation further provided.
(c) Any substance employed in the production of the copolymer that
is the subject of a regulation in parts 174, 175, 176, 177, 178 and
Sec. 179.45 of this chapter conforms with any specification in such
regulation.
(d) Substances employed in the production of the copolymer include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for use in the
copoly-mer and used in accordance with such sanction or approval.
(3) Substances which by regulation in parts 174, 175, 176, 177, 178
and Sec. 179.45 of this chapter may be safely used as components of
resinous or polymeric coatings and film used as food-contact surfaces,
subject to the provisions of such regulation.
(e) The copolymer conforms with the following specifications:
(1) The copolymer, when extracted with distilled water at reflux
temperature for 2 hours, yields total extractives not to exceed 0.05
percent.
(2) The copolymer, when extracted with ethyl acetate at reflux
temperature for 2 hours, yields total extractives not to exceed 0.7
percent.
(3) The copolymer, when extracted with n-hexane at reflux
temperature for 2 hours, yields total extractives not to exceed 0.05
percent.
[42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, 1984, as amended at 55
FR 34555, Aug. 23, 1990]
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