21 C.F.R. § 177.1395 Laminate structures for use at temperatures between 120 °F and 250 °F.
Title 21 - Food and Drugs
(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: [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]
Title 21: Food and Drugs
PART 177—INDIRECT FOOD ADDITIVES: POLYMERS
Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces
§ 177.1395 Laminate structures for use at temperatures between 120 °F and 250 °F.
------------------------------------------------------------------------ Substances Limitations------------------------------------------------------------------------Ethylene/1,3-phenylene oxyethylene For use only with isophthalate/terephthalate copolymer (CAS polyethylene terephthalate Reg. No. 87365-98-8) complying with as the food-contact layer, § 177.1345. 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 °F for 2 hours shall not yield m-pheny lenedioxy-O,O[prime]- 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 § For use with nonalcoholic 177.1500(b), item 13.2, of this chapter foods at temperatures not (CAS Reg. No. 25191-04-2). to exceed 100 °C (212 °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 °C (212 °F) for 5 hours.Nylon 6/66 resins complying with § For use only with: 177.1500(b), item 4.2 of this chapter 1. Nonalcoholic foods at (CAS Reg. 24993-04-2). temperatures not to exceed 82.2 °C (180 °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 °C (180 °F) for 5 hours. 2. Nonalcoholic foods at temperatures not to exceed 100 °C (212 °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 °C (212 °F) for 5 hours.Nylon 6/69 resins complying with § For use with nonalcoholic 177.1500(b), item 14, of this chapter foods under conditions of (CAS Reg. No. 51995-62-1). 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 °C (212 °F) for 8 hours) does not exceed 15 micrograms per square centimeter (100 micrograms per square inch).------------------------------------------------------------------------
