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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 April 1 2020.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2020]
[CITE: 21CFR177.1660]



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. 177.1660 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:

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]

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