Section

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1395]

[Page 258-259]

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

[[Page 259]]

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.
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 1/2C (180 1/2F).
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 1/2C
(180 1/2F) for 5 hours.
2. Nonalcoholic foods at
temperatures not to exceed
100 1/2C (212 1/2F).
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 1/2C (212
1/2F) 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]