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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 2019.

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, 2019]
[CITE: 21CFR177.1395]



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. 177.1395 Laminate structures for use at temperatures between 120 deg. F and 250 deg. F.

(a) The laminates identified in this section may be safely used at the specified temperatures. These articles are layered structures that are optionally bonded with adhesives. In these articles, the food-contact layer does not function as a barrier to migration of components from non-food-contact layers. The layers may be laminated, extruded, coextruded, or fused.

(b) Laminate structures may be manufactured from:

(1) Polymers and adjuvants complying with 177.1390 of this chapter.

(2) Any polymeric resin listed in these regulations so long as the use of the resin in the structure complies with the conditions of use (food type and time/temperature) specified in the regulation for that resin.

(3) Optional adjuvant substances used in accordance with 174.5 of this chapter.

(4) The following substances in non-food-contact layers only:

Substances Limitations
Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer (CAS Reg. No. 87365-98-8) complying with 177.1345For use only with polyethylene terephthalate as the food-contact layer, complying with 177.1630 under conditions of use C through G described in table 2 of 176.170(c) of this chapter. Laminate structures, when extracted with 8 percent ethanol at 150 deg. F for 2 hours shall not yield m-pheny lenedioxy-O,O'-diethyl isophthalate or cyclic bis(ethylene isophthalate) in excess of 7.8 micrograms/square decimeter (0.5 microgram/square inch) of food-contact surface.
Nylon 6/12 resins complying with 177.1500(b), item 13.2, of this chapter (CAS Reg. No. 25191-04-2)For use with nonalcoholic foods at temperatures not to exceed 100 deg. C (212 deg. F). Laminate structures with authorized food-contact materials yield no more than 0.15 milligram of epsilon-caprolactam and 0.04 milligram of omega-laurolactam per square inch when extracted with water at 100 deg. C (212 deg. F) for 5 hours.
Nylon 6/66 resins complying with 177.1500(b), item 4.2 of this chapter (CAS Reg. 24993-04-2)For use only with:
1. Nonalcoholic foods at temperatures not to exceed 82.2 deg. C (180 deg. F). Laminate structures with authorized food-contact materials yield no more than 0.15 milligram of epsilon-caprolactam per square inch when extracted with water at 82.2 deg. C (180 deg. F) for 5 hours.
2. Nonalcoholic foods at temperatures not to exceed 100 deg. C (212 deg. F). Laminate films with authorized food-contact materials yield no more than 0.15 milligram of epsilon-caprolactam per square inch when extracted with water at 100 deg. C (212 deg. F) for 5 hours.
Nylon 6/69 resins complying with 177.1500(b), item 14, of this chapter (CAS Reg. No. 51995-62-1)For use with nonalcoholic foods under conditions of use B, C, D, E, F, G, and H described in table 2 of 176.170 of this chapter. Laminate structures with authorized food-contact materials may contain nylon 6/69 resins provided that the nitrogen content of aqueous extracts of a representative laminate (obtained at 100 deg. C (212 deg. F) for 8 hours) does not exceed 15 micrograms per square centimeter (100 micrograms per square inch).

[52 FR 33575, Sept. 4, 1987, as amended at 53 FR 19772, May 31, 1988; 57 FR 43399, Sept. 21, 1992; 58 FR 32610, June 11, 1993; 62 FR 53957, Oct. 17, 1997]

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