21 CFR Ch. I (4–1–01 Edition)§177.1550
and ud in food-packaging adhesives complying with §175.105 of this chapter.
[42 FR 14572, Mar. 15, 1977]
E DITORIAL N OTE: For
F EDERAL R EGISTER ci-tations affecting §177.1520, e the List of CFR Sections Affected, which appears in the Finding Aids ction of the printed volume and on GPO Access.
§177.1550Perfluorocarbon resins. Perfluorocarbon resins identified in this ction may be safely ud as arti-cles or components of articles intended to contact food, subject to the provi-sions of this ction:
(a) Identity. For the purpo of this ction, perfluorocarbon resins are tho produced by: (1) The homopolymerization and/or copolym-erization of hexafluoropropylene and tetrafluoroethylene, and (2) the co-polymerization of perfluoropropylvinylether and tetra-fluoroethylene (CAS Reg. No. 26655–00–5). The resins shall meet the extrac-tives limitations in paragraph (d) of this ction.
(b) Optional components. The perfluorocarbon resins identified in paragraph (a) of this ction as well
as articles or coating made from the resins may include the following op-tional components except that the resin identified in paragraph (a)(2) of this ction may not be ud with the optional component, lithium polysilicate, mentioned in paragraph
(b)(4) of this ction.
(1) Substances generally recognized as safe (GRAS) in food or food pack-aging subject to any limitations cited on their u.
(2) Substances ud in accordance with a prior sanction or approval, sub-ject to any limitations cited in the prior sanction or approval.
(3) Substances authorized under ap-plicable regulations in this part and in parts 175 and 178 of this chapter and subject to any limitations prescribed therein.
(4) The following substances, subject to any limitations prescribed:
List of substances Limitations
Lithium polysilicate containing
not more than 20 weight per-
cent silica, not more than 2.1
percent lithium oxide and
having a maximum mole
ratio of Si02/Li20 of 8.5 to 1.
For u only as a compo-
nent of repeated-u
coatings not exceeding
0.030 millimeter (0.0012
inch) in thickness where
the coatings are thermally
cured at minimum sinter-
ing temperatures of 371
°C (700 °F). Lithium ex-
tractives shall not exceed
1.55 milligrams per
square decimeter (0.1
milligram per square inch)
of coating surface when
tested in accordance with
paragraph (e)(2) of this
ction.
Naphthalene sulfonic acid
formaldehyde condensate,
sodium salt.
For u only:
1. As a component of re-
peated-u coatings,
bad on the
perfluorocarbon resin
identified in paragraph
(a)(1) of this ction, not
to exceed 0.030 milli-
meter (0.0012 inch) in
thickness, and at a level
not to exceed 0.4 weight
percent of the coating.
2. As a component of re-
peated-u coatings,
bad on the
perfluorocarbon resin
identified in paragraph
(a)(2) of this ction, not
to exceed 0.10 millimeter
(0.004 inch) in thickness,
and at a level not to ex-
ceed 0.4 weight percent
of the coating.
(c) Optional processing. Poly- tetra-fluoroethylene resins may be irradi-ated by either a cobalt-60 aled source, at a maximum do of gamma radiation not to exceed 7.5 megarads, or an electron beam at energy levels not to exceed 2.5 million electron volts with a maximum dosage of 7.5 megarads, to produce lubricant pow-ders having a particle diameter of not more than 20 microns for u only as components of articles intended for re-peated u in contact with food.
(d) Specifications—(1) Infrared identi-fication. Perfluorocarbon resins can be identified by their characteristic infra-red spectra.
(2) Melt-viscosity. (i) The perfluoro-carbon resins identified in paragraph (a)(1) of this ction shall have a melt viscosity of not less than 104pois at 380 °C (716 °F) as determined by ASTM
Food and Drug Administration, HHS§177.1550 1A more detailed procedure of extraction
conditions is entitled, ‘‘Preparation of E x-
tracts,’’ which is incorporated by reference.
Copies are available from the Center for
Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Reg-ister, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
method D1238–82, ‘‘Standard Test Meth-od for Flow Rates of Thermoplastics by E xtrusion Plastometer,’’ which is in-corporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be ex-amined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. The melt viscosity of the perfluorocarbon resins identified in paragraph (a)(1) of this ction shall not vary more than 50 percent within one-half hour at 380 °C (716 °F).
(ii) Perfluorocarbon resins identified in paragraph (a)(2) of this ction shall have a melt viscosity of not less than 104pois at 372 °C (702 °F) as deter-mined by a more detailed method ti-tled ‘‘Deter
mination of Melt Viscosity, Molecular Weight Distribution Index and Viscosity Stability,’’ which is in-corporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(3) Thermal instability index. The ther-mal instability index of the tetra-fluoroethylene homopolymer shall not exceed 50 as determined by ASTM method D1457–56T, ‘‘Test for Thermal Instablility index of Tetrafluoro-ethylene Homopolymer’’ (Revid 1956), which is incorporated by reference. Copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the Office of the Fed-eral Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. The requirements of this paragraph do not apply to polytetrafluoroethylene resin lubricant powders described in paragraph (c) of this ction.
(e) Limitations.1(1) Perfluorocarbon-molded articles having a surface area of 6.45 square decimeters (100 square inches) or more and at least 1.27 milli-meters (0.05 inch) thick shall be ex-tracted at reflux temperatures for 2 hours parately with distilled water, 50 percent ethanol, n-heptane, and ethyl acetate.
(2) Perfluorocarbon resins identified in paragraphs (a)(1) and (2) of this c-tion and intended for u as coatings or components of coatings shall meet extractability limits prescribed in paragraph (e)(3) of this ction when the resins in the form of coatings de-scribed in paragraphs (e)(2) (i) and (ii) of this ction are extracted at reflux temperatures for 2 hours parately with distilled water, 8 percent ethanol, and n-heptane:
(i) Perfluorocarbon resin coatings bad on resins identified in paragraph (a)(1) of this ction shall be applied to both sides of a 0.025-millimeter (0.001 inch) thick aluminum foil to a thick-ness of 0.025 millimeter (0.001 inch) after thermal curing at 399 °C (750 °F) for 10 minutes. If a primer is ud, the total thickness of the primer plus top-coat shall equal 0.025 millimeter (0.001 inch) after heat curing.
(ii) Perfluorocarbon resin coatings bad on resins identified in paragraph (a)(2) of this ction shall be applied to both sides of a 0.025-millimeter (0.001 inch) thick aluminum foil to a thick-ness of 0.10 millimeter (0.004 inch) after thermal curing at 427 °C (800 °F) for 10 minutes. If a primer is ud, the total thickness of the primer plus topcoat shall equal 0.10 millimeter (0.004 inch) after heat curing.
(3) The extracted surfaces shall meet the following extractability limits: (i) Total extractives not to exceed 3.1 milligrams per square decimeter (0.2 milligram per square inch).
(ii) Fluoride extractives calculated as fluorine not to exceed 0.46 milligram per square decimeter (0.03 milligram per square inch).
(f) Conditions of u. Perfluorocarbon resins identified in paragraph (a)(2) of
21 CFR Ch. I (4–1–01 Edition)§177.1555
this ction are limited to u as coat-ings or components of coatings for arti-cles intended for repeated food-contact u.
[43 FR 44834, Sept. 29, 1978, as amended at 47 FR 11843, Mar. 19, 1982; 47 FR 14699, Apr. 6, 1982; 49 FR 10109, Mar. 19, 1984; 50 FR 1502, Jan. 11, 1985; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996]
§177.1555Polyarylate resins. Polyarylate resins (CAS Reg. No. 51706–10–6) may be safely ud as arti-cles or components of articles intended for u in contact with food in accord-ance with the following prescribed con-ditions:
(a) Identity. Polyarylate resins (1, 3-benzenedicarboxylic acid, diphenyl ester, polymer with diphenyl 1,4-benzenedicarboxylate and 4-4′-(1-methylethylidine) bis(phenol)) are formed by melt polycondens
ation of bisphenol-A with diphenylisophthalate and diphenylterephthalate.
(b) Specifications. (1) The finished co-polymers shall contain from 70 to 80 weight percent of polymer units de-rived from diphenylisophthalate and 20 to 30 weight percent of polymer units derived from diphenylterephthalate. (2) Polyarylate resins shall have a minimum weight average molecular weight of 20,000.
(3) Polyarylate resins may be identi-fied by their characteristic infrared spectra.
(c) Extractive limitations. The finished polyarylate resins in sheet form at least 0.5 millimeter (0.020 inch) thick, when extracted with water at 121 °C (250 °F) for 2 hours, shall yield total nonvolatile extractives not to exceed 2.33 micrograms per square centimeter (15 micrograms per square inch) of the expod resin surface.
(d) Limitations. Polyarylate resin ar-ticles may be ud in contact with all foods except beverages containing more than 8 volume percent ethanol under conditions of u A through H, described in table 2 of §176.170(c) of this chapter.
[52 FR 35540, Sept. 22, 1987]
§177.1556Polyaryletherketone resins. The poly(oxy-1,4-phenylenecarbonyl-1,4-phenyleneoxy-1,4-
phenylenecarbonyl-1,4-phenylenecarbonyl-1,4-phenylene) res-ins (CAS Reg. No. 55088–54–5 and CAS Reg. No. 60015–05–6 and commonly re-ferred to as polyaryletherketone res-ins) identified in paragraph (a) of this ction may be safely ud as articles or components of articles intended for repeated u in contact with food, sub-ject to the provisions of this ction. (a) Identity. Polyaryletherketone res-ins consist of basic resins produced by reacting 4,4′-diphenoxy benzophenone and terephthaloyl dichloride in such a way that the finished resins have a minimum weight average molecular weight of 20,000 grams per mole, as de-termined by light scattering measure-ments in sulfuric acid at room tem-perature.
(b) Optional adjuvant substances. The basic polyaryletherketone resins iden-tified in paragraph (a) of this ction may contain optional adjuvant sub-stances required in the production of such basic resins. The adjuvants may include substances ud in accordance with §174.5 of this chapter and the fol-lowing:
(1) Benzoyl chloride, poly(tetrafluoro ethylene).
(2) [Rerved]
(c) Extractive limitations. The finished food-contact article yields net total ex-tractives in each extracting solvent not to exceed 0.052 milligram per square inch (corresponding to 0.008 mil-ligram per square centimeter) of food-contact surface, when extracted at reflux temperature for 2 hours with the following solvents: Distilled water, 50 percent (by volume) ethyl alcohol in distilled water, 3 percent acetic acid (by weight) in distilled water, and n-heptane.
(d) In testing the finished food-con-tact article made of polyaryletherketone resin, u a pa-rate test sample for each required ex-tracting solvent.
[61 FR 42381, Aug. 15, 1996]
§177.1560Polyarylsulfone resins. Polyarylsulfone resins (CAS Reg. No. 79293–56–4) may be safely ud as arti-cles or components of articles intended for u in contact with food, at tem-peratures up to and including normal baking temperatures, in accordance
