[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1240]

[Page 242]
 
                        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 isophthalate 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]