[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1315]
[Page 251-254]
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. 177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate
copolymers.
Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymer may
be safely used as articles or components of articles intended for use in
contact with food subject to provisions of this section and of part 174
of this chapter.
(a) Identity. For the purposes of this section, ethylene-1,4-
cyclohexylene dimethylene terephthalate copolymers (1,4-benzene
dicarboxylic acid, dimethyl ester, polymerized with 1,4-
cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25640-14-6) or
(1,4-benzenedicarboxylic acid, polymerized with 1,4-
cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25038-91-9) are
basic copolymers meeting the specifications prescribed in paragraph (b)
of this section, to which may have been added certain optional
substances required in their production or added to impart desired
physical or technical properties.
(b) Specifications:
[[Page 252]]
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Maximum
extractable
fractions of the
copolymer in the
finished form at
Ethylene-1,4-cyclohexylene specified
dimethylene terephthalate Inherent viscosity temperatures and Test for Conditions of use
copolymers times (expressed orientability
in micrograms of
the terephthaloyl
moletles/square
centimeter of food-
contact surface)
----------------------------------------------------------------------------------------------------------------
1. Non-oriented ethylene-1,4- Inherent viscosity (1) 0.23 microgram No test required.. In contact with
cyclohexylene dimethylene of a 0.50 percent per square foods, including
terephthalate copolymer is the solution of the centimeter (1.5 foods containing
reaction product of dimethyl copolymer in micrograms per not more than 25
terephthalate or terephthalic phenol-tet square inch) of percent (by
acid with a mixture containing rachloroethane food-contact volume) aqueous
99 to 66 mole percent of (60:40 ratio wt/ surface when alcohol,
ethylene glycol and 1 to 34 wt) solvent is extracted with excluding
mole percent of 1,4-cyclo- not less than water added at carbonated
hexanedimethanol (70 percent 0.669 as 82.2 [deg]C (180 beverages and
trans isomer, 30 percent cls determined by [deg]F) and beer. Conditions
isomer). using a Wagner allowed to cool of hot fill not
viscometer (or to 48.9 [deg]C to exceed 82.2
equivalent) and (120 [deg]F) in [deg]C (180
calculated from contact with the [deg]F), storage
the following food-contact at temperatures
equation: article. not in excess of
Inherent 48.9 [deg]C (120
viscosity = [deg]F). No
(Natural thermal treatment
logarithm of (Nr)/ in the container.
(c) where:
Nr=Ratio of flow
time of the
polymer solution
to that of the
solvent, and
c=concentration
of the test
solution
expressed in
grams per 100
milliliters.
......do.......... (2) 0.23 microgram ......do.......... Do.
per square
centimeter (1.5
micrograms per
square inch) of
food-contact
surface when
extracted with 3
percent (by
volume) aqueous
acetic acid added
at 82.2 [deg]C
(180 [deg]F) and
allowed to cool
to 48.9 [deg]C
(120 [deg]F) in
contact with the
food-contact
article.
......do.......... (3) 0.08 microgram ......do.......... Do.
per square
centimeter (0.5
microgram per
square inch) of
food-contact
surface when
extracted for 2
hours with n-
heptane at 48.9
[deg]C (120
[deg]F). The
heptane
extractable
results are to be
divided by a
factor of 5.
......do.......... (4) 0.16 microgram ......do.......... Do.
per square
centimeter (1.0
microgram per
square inch) of
food-contact
surface when
extracted for 24
hours with 25
percent (by
volume) aqueous
ethanol at 48.9
[deg]C (120
[deg]F).
[[Page 253]]
2. Oriented ethylene-1,4- ......do.......... (1) 0.23 microgram When extracted In contact with
cyclohexylene dimethylene per square with heptane at nonalcoholic
terephthalate copolymer is the centimeter (1.5 65.6 [deg]C (150 foods including
reaction product of dimethyl micrograms per [deg]F) for 2 carbonated
terephthalate or terephthalic square inch) of hours: beverages.
acid with a mixture containing food-contact terephthaloyl Conditions of hot
99 to 85 mole percent ethylene surface of the moieties do not fill not
glycol and 1 to 15 mole percent oriented exceed 0.09 exceeding 87.8
of 1,4-cyclohexane-di-methanol copolymer when microgram per [deg]C (190
(70 percent trans isomer, 30 extracted with square centimeter [deg]F), storage
percent cls isomer). water added at (0.60 microgram at temperatures
87.8 [deg]C (190 per square inch) not in excess of
[deg]F) and of food-contact 48.9 [deg]C (120
allowed to cool surface. [deg]F). No
to 48.9 [deg]C thermal treatment
(120 [deg]F) in in the container.
contact with the
food-contact
article.
......do.......... (2) 0.23 microgram ......do.......... Do.
per square
centimeter (1.5
micrograms per
square inch) of
food-contact
surface of
oriented
copolymer when
extracted with 3
percent (by
volume) aqueous
acetic acid added
at 87.8 [deg]C
(190 [deg]F) and
allowed to cool
to 48.9 [deg]C
(120 [deg]F) in
contact with the
food-contact
article.
......do.......... (3) 0.08 microgram ......do.......... Do.
per square
centimeter (0.5
microgram per
square inch) of
food-contact
surface of
oriented
copolymer when
extracted for 2
hours with n-
heptane at 48.9
[deg]C (120
[deg]F). The
heptane
extractable
results are to be
divided by a
factor of 5.
......do.......... (4) 0.23 microgram ......do.......... In contact with
per square foods and
centimeter (1.5 beverages
micrograms per containing up to
square inch) of 20 percent (by
food-contact volume) alcohol.
surface of Conditions of
oriented thermal treatment
copolymer when in the container
extracted with 20 not exceeding
percent (by 65.6 [deg]C (150
volume) aqueous [deg]F) for 20
ethanol heated to minutes. Storage
65.6 [deg]C (150 at temperatures
[deg]F) for 20 not in excess of
minutes and 48.9 [deg]C (120
allowed to cool [deg]F).
to 48.9 [deg]C
(120 [deg]F) in
contact with the
food-contact
article.
......do.......... (5) 0.23 microgram ......do.......... In contact with
per square foods and
centimeter (1.5 beverages
micrograms per containing up to
square inch) of 50 percent (by
food-contact volume) alcohol.
surface of Conditions of
oriented fill and storage
copolymer when not exceeding
extracted with 50 48.9 [deg]C (120
percent (by [deg]F). No
volume) aqueous thermal treatment
ethanol at 48.9 in the container.
[deg]C (120
[deg]F) for 24
hours.
[[Page 254]]
3. Ethylene-1,4-cyclohexylene No test required.. For each No test required.. For each
dimethylene terephthalate corresponding corresponding
copolymer is the reaction condition of use, specification,
product of dimethyl must meet may be used as a
terephthalate or terephthalic specifications base sheet and
acid with a mixture containing described in Sec. base polymer in
99 to 95 mole percent of 177.1630(f), accordance with
ethylene glycol and 1 to 5 mole (g), (h), or (j). conditions of use
percent of 1,4- described in Sec.
cyclohexanedimethanol (70 177.1630(f),
percent trans isomer, 30 (g), (h), or (j).
percent cis isomer).
----------------------------------------------------------------------------------------------------------------
(c) Analytical method for determination of extractability. The total
extracted terephthaloyl moieties can be determined in the extracts,
without evaporation of the solvent, by measuring the ultraviolet (UV)
absorbance at 240 nanometers. The spectrophotometer (Varian 635-D, or
equivalent) is zeroed with a sample of the solvent taken from the same
lot used in the extraction tests. The concentration of the total
terephthaloyl moieties in water, 3 percent acetic acid, and in 8 percent
aqueous alcohol is calculated as bis(2-hydroxyethyl terephthalate) by
reference to standards prepared in the appropriate solvent.
Concentration of the terephthaloyl moieties in heptane is calculated as
cyclic trimer
(C6H4CO2C2H4CO2
)3, by reference to standards prepared in 95:5 percent (v/v)
heptane: tetrahydrofuran.
[45 FR 39252, June 10, 1980, as amended at 47 FR 24288, June 4, 1982; 49
FR 25629, June 22, 1984; 51 FR 22929, June 24, 1986; 60 FR 57926, Nov.
24, 1995]