[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: 21CFR177.2410]
[Page 337-338]
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 C_Substances for Use Only as Components of Articles Intended for
Repeated Use
Sec. 177.2410 Phenolic resins in molded articles.
Phenolic resins identified in this section may be safely used as the
food-contact surface of molded articles intended for repeated use in
contact with nonacid food (pH above 5.0), in accordance with the
following prescribed conditions:
(a) For the purpose of this section, the phenolic resins are those
produced when one or more of the phenols listed in paragraph (a)(1) of
this section are made to react with one or more of the aldehydes listed
in paragraph (a)(2) of this section, with or without aniline and/or
anhydro-formaldehyde aniline (hexahydro-1, 3,5-triphenyl-s-triazine):
(1) Phenols:
p-tert-Amylphenol.
p-tert-Butylphenol.
o-, m-, and p-Cresol.
p-Octylphenol.
Phenol.
o- and p-Phenylethylphenol mixture produced when phenol is made to react
with styrene in the presence of sulfuric acid catalyst.
(2) Aldehydes:
Acetaldehyde.
Formaldehyde.
Paraldehyde.
(b) Optional adjuvant substances employed in the production of the
phenolic resins or added thereto to impart desired technical or physical
properties include the following:
Asbestos fiber............................
Barium hydroxide.......................... For use as catalyst.
Calcium stearate.......................... For use as lubricant.
Carbon black (channel process)............
Diatomaceous earth........................
Glass fiber...............................
Hexamethylenetetramine.................... For use as curing agent.
Mica......................................
Oxalic acid............................... For use as catalyst.
[[Page 338]]
Zinc stearate............................. For use as lubricant.
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(c) The finished food-contact article, when extracted with distilled
water at reflux temperature for 2 hours, using a volume-to-surface ratio
of 2 milliliters of distilled water per square inch of surface tested,
shall meet the following extractives limitations:
(1) Total extractives not to exceed 0.15 milligram per square inch
of food-contact surface.
(2) Extracted phenol not to exceed 0.005 milligram per square inch
of food-contact surface.
(3) No extracted aniline when tested by a spectrophotometric method
sensitive to 0.006 milligram of aniline per-square inch of food-contact
surface.
(d) In accordance with good manufacturing practice, finished molded
articles containing the phenolic resins shall be thoroughly cleansed
prior to their first use in contact with food.
Additives that reference this regulation: |
