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

Home > Regulations > Indirect food additives: Polymers > 177.1395 Laminate structures for use at temperatures between 120 °F and 250 °F.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1395]

[Page 272-273]
 
                        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.  177.1395  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 Sec.  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 Sec.  174.5 
of this chapter.
    (4) The following substances in non-food-contact layers only:

------------------------------------------------------------------------
                Substances                           Limitations
------------------------------------------------------------------------
Ethylene/1,3-phenylene oxyethylene          For use only with
 isophthalate/terephthalate copolymer (CAS   polyethylene terephthalate
 Reg. No. 87365-98-8) complying with Sec.    as the food-contact layer,
  177.1345.                                  complying with Sec.
                                             177.1630 under conditions
                                             of use C through G
                                             described in table 2 of
                                             Sec.   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 Sec.       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 [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.

[[Page 273]]


Nylon 6/66 resins complying with Sec.       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 [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 Sec.       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
                                             Sec.   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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1395


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