[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: 21CFR177.1390]
[Page 269-272]
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. 177.1390 Laminate structures for use at temperatures of 250 [deg]F
and above.
(a) The high-temperature laminates identified in this section may be
safely used for food contact at temperatures not exceeding 135 [deg]C
(275 [deg]F) unless otherwise specified. These articles are layered
constructions that are optionally bonded with adhesives. The interior
(food-contact) layer(s) may be separated from the exterior layer(s) by a
functional barrier, such as aluminum foil. Upon review of the physical
properties of a particular construction, the Food and Drug
Administration may consider other layers to serve as functional
barriers. This regulation is not intended to limit these constructions
as to shape, degree of flexibility, thickness, or number of layers.
These layers may be laminated, extruded, coextruded, or fused.
(b) When containers subject to this regulation undergo heat
sterilization to produce shelf-stable foods, certain control measures
(in addition to the food additive requirements in paragraphs (c) and (d)
of this section) are necessary to ensure proper food sterilization and
package integrity. Refer to parts 108, 110, 113, and 114 of this chapter
for details.
(c) Subject to the provisions of this paragraph, food-contact
articles produced from high-temperature laminates may be safely used to
package all food types except those containing more than 8 percent ethyl
alcohol.
(1) Polymeric films/layers. Films or layers not separated from food
by a functional barrier must meet the following requirements:
(i) Films/layers may consist of the following:
(a) Polyolefin resins complying with item 2.2 or 3.2 of the table in
Sec. 177.1520(c).
(b) Polymeric resin blends formulated from a base polymer complying
with item 2.2 or 3.2 of the table in Sec. 177.1520(c) blended with no
more than 10 percent by weight of a copolymer of ethylene and vinyl
acetate complying with Sec. 177.1350.
(c) Polymeric resin blends formulated from a base polymer complying
with item 2.2 or 3.2 of the table in Sec. 177.1520(c) blended with no
more than 38 percent by weight of a homopolymer of isobutylene complying
with Sec. 177.1420(a)(1).
(d) Polyethylene phthalate resins complying with Sec.
177.1630(e)(4) (i) and (ii).
(e) Nylon MXD-6 resins that comply with item 10.3 of the table in
Sec. 177.1500(b) of this chapter when extracted with water and heptane
under the conditions of time and temperature specified for condition of
use A, as set forth in Table 2 of Sec. 176.170(c) of this chapter.
(f) Nylon \6/12\ resins (CAS Reg. No. 25191-04-2) complying with
item 13.3 of the table in Sec. 177.1500(b), for use as nonfood-contact
layers of laminated films and in rigid multilaminate constructions with
polypropylene outer layers. Laminate structures with authorized food-
contact materials yield no more than 0.15 milligrams of epsilon-
caprolactam and 0.04 milligrams of omega-laurolactam per square inch
when extracted with 95 percent ethanol at 121 [deg]C (250 [deg]F) for 2
hours.
[[Page 270]]
(g) Polymeric resins that comply with an applicable regulation in
this chapter which permits food type and time/temperature conditions to
which the container will be exposed, including sterilization processing.
(ii) Adjuvants used in these layers must comply with an applicable
regulation that permits food type and time/temperature conditions to
which the container will be exposed, including sterilization processing.
(2) Adhesives. The use of adhesives in these containers is optional.
Adhesives may be formulated from the following substances, subject to
the prescribed limitations:
(i) Any substance suitable for use in formulating adhesives that
complies with an applicable regulation of this chapter which permits
food type and time/temperature conditions to which the container will be
exposed, including sterilization processing.
(ii) Substances complying with Sec. 175.105 of this chapter may be
used in these constructions, provided they are separated from the
interior (food-contact) layer(s) by a functional barrier as discussed
under paragraph (a) of this section.
(iii) Maleic anhydride adduct of polypropylene complying with Sec.
175.300 of this chapter.
(iv) Polyester-urethane adhesive for use at temperatures not
exceeding 121 [deg]C (250 [deg]F) and formulated from the following:
(a) Polyester-urethanediol resin prepared by the reaction of a
mixture of polybasic acids and polyhydric alcohols listed in Sec.
175.300(b)(3)(vii) of this chapter, 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9) and optional
trimethoxysilane coupling agents containing amino, epoxy, ether, and/or
mercapto groups not to exceed 3 percent by weight of the cured adhesive.
(b) Urethane cross-linking agent comprising not more than 25 percent
by weight of the cured adhesive and formulated from 3-isocyanatomethyl-
3,5,5-trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9) adduct of
trimethylol propane (Cas Reg. No. 77-99-6) and/or 1,3-
bis(isocyanatomethyl) benzene (CAS Reg. No. 25854-16-4) adduct of
trimethylol propane.
(v) Polyester-epoxy-urethane adhesives formulated from the
following:
(a) Polyester resin formed by the reaction of polybasic acids and
polyhydric alcohols listed in Sec. 175.300(b)(3)(vii) of this chapter.
Azelaic acid may also be used as a polybasic acid.
(b) Epoxy resin listed in Sec. 175.300(b)(3)(viii)(a) of this
chapter and comprising no more than 30 percent by weight of the cured
adhesive.
(c) Urethane cross-linking agent comprising no more than 14 percent
weight of the cured adhesive and formulated from 3-isocyanatomethyl-
3,5.5-trimethylcyclohexyl isocyanate cyanurate (CAS Reg. No. 53880-05-
0).
(vi) Polyurethane-polyester resin-epoxy adhesives formulated from
the following mixture:
(a)(1) Polyester-polyurethanediol resins prepared by the reaction of
a mixture of polybasic acids and polyhydric alcohols listed in Sec.
175.300(b)(3)(vii) of this chapter and 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9).
(2) Polyester resin formed by the reaction of polybasic acids and
polyhydric alcohols listed in Sec. 175.300(b)(3)(vii) of this chapter.
Additionally, azelaic acid and 1,6-hexanediol may also be used as
reactants in lieu of a polyhydric alcohol.
(3) Epoxy resin listed in Sec. 175.300(b)(3)(viii)(a) of this
chapter and comprising not more than 5 percent by weight of the cured
adhesive.
(4) Optional trimethoxy silane curing agents, containing amino,
epoxy, ether, or mercapto groups not in excess of 3 percent of the cured
adhesive.
(b) Urethane cross-linking agent, comprising not more than 20
percent by weight of the cured adhesive, and formulated from trimethylol
propane (CAS Reg. No. 77-99-6) adducts of 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9) or 1,3-
bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4).
(vii) Polyester-polyurethane resin-acid dianhydride adhesives for
use at temperatures not to exceed 121 [deg]C (250 [deg]F), in contact
only with food Types I,
[[Page 271]]
II, VIA, VIB, VIIB, and VIII as described in Table I of Sec. 176.170 of
this chapter, and formulated from the following mixture:
(a)(1) Polyesterpolyurethanediol resins prepared by the reaction of
a mixture of polybasic acids and polyhydric alcohols listed in Sec.
175.300(b)(3)(vii) of this chapter and 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9). Additionally,
dimethylol propionic acid and 1,6-hexanediol may be used alone or in
combination as reactants in lieu of a polybasic acid and a polyhydric
alcohol.
(2) Acid dianhydride formulated from 3a,4,5,7a-tetrahydro-7-methyl-
5-(tetrahydro-2,5-dioxo-3-furanyl)-1,3-isobenzofurandione (CAS Reg. No.
73003-90-4), comprising not more than one percent of the cured adhesive.
(b) Urethane cross-linking agent, comprising not more than twelve
percent by weight of the cured adhesive, and formulated from trimethylol
propane (CAS Reg. No. 77-99-6) adducts of 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9) and/or 1,3-
bis(isocyanatomethyl)benzene (CAS Reg. No. 363-48-31).
(3) Test specifications. These specifications apply only to
materials on the food-contact side of a functional barrier, if present.
All tests must be performed on containers made under production
conditions. Laminated structures submitted to extraction procedures must
maintain complete structural integrity (particularly with regard to
delamination) throughout the test.
(i) Nonvolatile extractives. (a) For use at temperatures not to
exceed 121 [deg]C (250 [deg]F): The container interior (food-contact
side) shall be extracted with deionized distilled water at 121 [deg]C
(250 [deg]F) for 2 hours.
(1) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraphs
(c)(2)(i), (c)(2)(ii), (c)(2)(iii), (c)(2)(iv), and (c)(2)(vii) of this
section shall not exceed 0.0016 milligram per square centimeter (0.01
milligram per square inch) as determined by a method entitled
``Determination of Non-Volatile Chloroform Soluble Residues in Retort
Pouch Water Extracts,'' which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, and may be examined at the Center for Food Safety and
Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD
20740, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.
(2) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraph (c)(2)(v)
of this section shall not exceed 0.016 milligram per square centimeter
(0.10 milligram per square inch) as determined by a method titled
``Determination of Non-volatile Chloroform Soluble Residues in Retort
Pouch Water Extracts,'' which is incorporated by reference in paragraph
(c)(3)(i)(a)(1) of this section.
(b) For use at temperatures not to exceed 135 [deg]C (275 [deg]F):
The container interior (food-contact side) shall be extracted with
deionized distilled water at 135 [deg]C (275 [deg]F) for 1 hour.
(1) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using no adhesive, or adhesives listed in
paragraphs (c)(2) (i), (ii), and (iii) of this section shall not exceed
0.0020 milligram per square centimeter (0.013 milligram per square inch)
as determined by a method titled ``Determination of Non-volatile
Chloroform Soluble Residues in Retort Pouch Water Extracts,'' which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (c)(3)(i)(a)(1) of this section.
(2) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraph (c)(2)(v)
of this section shall not exceed 0.016 milligram per square centimeter
(0.10 milligram per square inch) as determined by a method titled
``Determination of Non-volatile Chloroform Soluble Residues in Retort
[[Page 272]]
Pouch Water Extracts,'' which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(3)(i)(a)(1) of this section.
(3) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraph
(c)(2)(vi) of this section shall not exceed 0.008 milligram per square
centimeter (0.05 milligram per square inch) as determined by a method
entitled, ``Determination of Non-volatile Chloroform Soluble Residues in
Retort Pouch Water Extracts,'' which is incorporated by reference in
paragraph (c)(3)(i)(a)(1) of this section.
(ii) Volatiles. Volatile substances employed in the manufacture of
high-temperature laminates must be removed to the greatest extent
possible in keeping with good manufacturing practice prescribed in Sec.
174.5(a) of this chapter.
(d) Nylon 12/aluminum foil high-temperature laminates: Subject to
the provisions of this paragraph, containers constructed of nylon 12
laminated to aluminum foil may be safely used at temperatures no greater
than 250 [deg]F (121 [deg]C) in contact with all food types except those
containing more than 8 percent alcohol.
(1) The container is constructed of aluminum foil to which nylon 12
film is fused. Prior to fusing the nylon 12, the aluminum foil may be
optionally precoated with a coating complying with Sec. 175.300 of this
chapter.
(2) Nylon 12 resin complying with Sec. 177.1500 and having an
average thickness not to exceed 0.0016 inch (41 microns) may be used as
the food-contact surface of the container.
(3) Container test specifications. On exposure to distilled water at
250 [deg]F (121 [deg]C) for 2 hours, extractives from the food-contact
side of the nylon 12 multilayered construction shall not exceed 0.05
milligram per square inch (0.0078 milligram per square centimeter) as
total nonvolatile extractives.
[45 FR 2843, Jan. 15, 1980, as amended at 47 FR 49639, Nov. 2, 1982; 48
FR 236, Jan. 4, 1983; 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22,
1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, Sept. 4, 1987; 53 FR 39084,
Oct. 5, 1988; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996; 63
FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, 1999; 64 FR 46272, Aug. 25,
1999; 69 FR 15668, Mar. 26, 2004]
Additives that reference this regulation: |
