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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 Dec 22, 2023.

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

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[Code of Federal Regulations]
[Title 21, Volume 3]
[CITE: 21CFR177.1240]



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 177 -- INDIRECT FOOD ADDITIVES: POLYMERS

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 § 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 § 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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